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<h3>Job Description</h3>
Job Description
We are looking for Quality Assurance Validation contractors to join our growing QA Validation group in Boston MA. Positions range from 6 to 12 months. The roles are expected to be onsite in Boston, MA. 
Responsibilities:
<ul>
<li>Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.</li>
</ul>
<ul>
<li>Provide QA oversight for periodic review and requalification program.</li>
<li>Perform review of CMMS records related to asset management including asset release, database requests, and work orders.</li>
<li>Author and perform review of SOPs in Veeva.</li>
</ul>
<ul>
<li>Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).</li>
<li>Ensure compliance of validation activities with applicable GMP regulations, industry guidance, and internal SOPs.</li>
<li>Collaborate with cross-functional teams (Validation, QA, Engineering, Manufacturing, QC) to support timely execution of validation projects.</li>
<li>Participate in change control assessments, risk assessments, and deviation investigations related to validation.</li>
<li>Provide QA input during validation planning and execution phases.</li>
<li>Support audits and regulatory inspections by providing validation documentation and addressing QA-related inquiries.</li>
<li>Ensure data integrity and documentation accuracy in all validation records.</li>
<li>Maintain cu</li>
</ul>
Requirements
Requirements:
<ul>
<li>Bachelor’s degree in a technical discipline with 5+ years validation and/or quality assurance experience. In lieu of degree, 7+ years of equivalent work experience is required. </li>
<li>Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation. </li>
<li>Prior experience working in cell and gene therapy manufacturing preferred. </li>
<li>Prior experience working with contract manufacturing preferred. </li>
<li>Experience with Kneat strongly preferred. </li>
<li>Applies collaborative approach to problem solving and is experienced with risk-based decision making. </li>
<li>Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.</li>
</ul>
Benefits
<ul>
<li>Contract </li>
<li>6 to 12 months</li>
</ul>

Quality Assurance Validation Contractor

<h3>Job Description</h3>
Job Description
We're quickly growing and super excited for you to join us! 
About Topsort
At Topsort, we believe in the mission of democratizing the secret technologies of the walled gardens and creating a privacy-first cookie-free world of clean advertising with modern tech, friendly products, and AI. We believe in making advertising intuitive, intelligent, and genuinely cool, without any of the creepy ads or cookie-obsession (well, maybe just the chocolate ones). In a rapidly changing industry, we're on a mission to democratize monetization access for all and ensure that advertising doesn't leave any brand or seller feeling confused or overwhelmed
Today, Topsort has 5 major hubs worldwide, and employees in 13+ countries, including Menlo Park, Boston, Santiago Chile, Sao Paulo Brazil, Barcelona Spain, and Sydney Australia. We are a truly global company that was born in the pandemic that's had rapid growth since out of a genius product, a customer-first mentality, and a hardworking team of talented individuals. Since our founding in 2021, we've gained customers in retail, marketplaces, and delivery apps in 40+ countries and quickly approaching the #1 position in the industry.
Do you enjoy a fast-paced environment? Do you like seeing your work create real-time impact, being part of a rocket ship from the very beginning? Let's do the unimaginable - let's make ads clean and cool again, with AI and modern technology.
What it's like to work at Topsort
Our team is all about straightforward communication, embracing feedback without taking it personally, and fostering a super collaborative environment. It's a sports team that's hyper focused on winning, collaborative internally, and competitive externally - never the other way around. We thrive on working in the open, lifting each other up, and getting things done with a sense of urgency. We're the kind of team that loves making bold choices, sharing extraordinary opinions, and maintaining a 100 mph pace. No endless meetings here – if it can be done today, we're all about getting it done today.
About the Role:
We are looking for a hands-on and client-facing Software Engineers - Integrations focuesd to join our team at Topsort. In this role, you will play a pivotal part in translating real-world business needs into powerful, scalable product solutions. You'll collaborate directly with sales, product, and engineering teams to support Pre-sales conversations - partner with sales to understand customer pain points, lead technical implementations with Topsort. 
You will:
<ul>
<li>Engage with Prospects &amp; Clients: Work closely with the sales and customer success teams to understand client requirements and propose tailored technical solutions.</li>
<li>Own Technical Discovery &amp; Demos: Lead technical conversations and run product demonstrations that align our platform's capabilities with customer needs.</li>
<li>Solution Design: Translate business challenges into feasible product configurations, data integrations, and implementation plans.</li>
<li>Support RFPs and Security Questionnaires: Respond to technical and compliance-related questions in RFPs and trust questionnaires.</li>
<li>Own the entire integration process – You won't just be following instructions; you'll be leading integrations end-to-end, solving complex challenges, and acting as a trusted technical advisor to our clients.</li>
<li>Be the bridge between tech &amp; customer success – Work directly with clients, engineers, and product teams to deeply understand their needs and ensure seamless API integrations. Your solutions won't just be functional—they'll be impactful and user-friendly, strengthening long-term customer relationships.</li>
</ul>
What (we think) you need to be successful - we're open to not checking all the boxes and be proven wrong by outlier candidates as well! 
<ul>
<li>Industry Experience: 3+ years in software development, managing integrations, APIs, system interoperability, or ad tech is a plus. etc.</li>
<li>API Expertise: Strong experience with RESTful APIs, authentication methods (OAuth), and data formats (JSON, XML).</li>
<li>Proven ability to communicate complex technical ideas clearly to both technical and non-technical audiences.</li>
<li>Demonstrated success working directly with enterprise clients, understanding their operational realities and constraints.</li>
<li>Comfortable navigating ambiguity and making decisions with incomplete information.</li>
<li>Clear sense of ownership — you lead the solution from pre-sales design through implementation and post-sale success.</li>
<li>Experience collaborating with product and engineering teams to shape customer-driven roadmaps.</li>
<li>Bachelor's degree and above in Computer Science, Engineering, or related field from a top school. </li>
<li>CRM &amp; Platforms: Familiarity with customer relationship management (CRM) tools and integration platforms.</li>
<li>Communication &amp; Stakeholder Management: Strong ability to interact with both technical and non-technical audiences, translating complex concepts into actionable insights.</li>
</ul>
Topsort Culture
<ul>
<li>Speed: We work hard, set aggressive goals and execute flawlessly to accomplish them. We give candid feedback, push each other to set higher goals and produce more impact by always thinking "how do we do this faster and better"</li>
<li>Fast Growth: We believe startup scaleup is just like a team sport. It's been written in our motto since day 1 that we are collaborative internally, competitive externally, and never the other round around. You are ultimately surrounded by just different people that are all here to help you get the job done and shine as a team. </li>
<li>Intellectual Rigor and Individuality: We were born in the pandemic by Stanford and Harvard alum cofounders who offer (at least) once a year in person offsite gathering. You'll be welcomed by coworkers in 11 countries that all bring a unique perspective to the company from day 1. From personalized birthday gifts to work anniversaries, and management training program or in-person gatherings or career talks and mentorships, part-time DJs and tik-tok vloggers are also commercial leaders and technical staff at Topsort. We don't take management with a cookie cutter approach - but rather we cherish your quarks and think it makes us stronger. </li>
<li>Company Offsite and Industry Exposure: Once a year Topsorters get together as a whole and also meet customers and really spend time to get feedback </li>
<li>401K Matching and Comprehensive benefits: We provide a generous and comprehensive set of health benefits, including vision, dental, and a 3% 401K matching as soon as you join! </li>
<li>Working Equipment and Hubs: our team is global and also centered around hubs, that means you're welcome to create a hybrid work schedule, and encouraged to travel to other hubs to collaborate. We provide working devices of your choice and surprise swags for special events. </li>
<li>Flexible PTO schedule with floating holidays - we encourage Topsorters to take time off and recharge, and respect different cultural norms so offer floating holidays to accommodate the celebrations you'd like. </li>
<li>Meditation App, Birthday and Anniversary Celebrations - we like little surprises and remember the key moments to celebrate with you! </li>
</ul>
Do you sound like the right fit? Let's dive right in!

Software Engineer-Integrations North America

<h3>Job Description</h3>
Job Description
Overview
At Community Financial System, Inc. (CFSI), we are dedicated to providing our customers with friendly, personalized, high-quality financial services and products. Our retail division, Community Bank, N.A., operates more than 200 customer facilities across Upstate New York, Northeastern Pennsylvania, Vermont and Western Massachusetts. Beyond retail banking, we also offer commercial banking, wealth management, investment management, insurance and risk management, and benefit plan administration.
Just as our employees are committed to helping our customers manage their finances, we’re committed to our employees. After all, they make it happen for our customers every day.
To ensure our people can enjoy long and successful careers here at CFSI, we offer competitive compensation, great benefits, and professional development and advancement opportunities. As an equal-opportunity workplace and affirmative-action employer, we celebrate and support a diverse workplace for the benefit of all: our employees, customers and communities.
 
Responsibilities
As a Technology Support Specialist you will:
<ul>
<li>Act as the first point of contact with customers responding to their electronic and/or telephone requests. Typical issues may include password resets, application issues/questions and troubleshooting hardware/connectivity issues for various software systems.</li>
<li>Provide a high level of customer service while developing and maintaining a positive &amp; professional relationship.</li>
<li>Provides general PC/Network and printer support to all internal employees.</li>
<li>Provide phone, remote, and/or in person support to all employees within the Community Bank Systems, Inc.</li>
<li>Ability to answer questions and solves problems on hardware, software and communication related issues.</li>
<li>Documents all requests, the work performed and resolution comments within the Help Desk ticketing system.</li>
<li>The ability to work internally with other IT related departments (System Admin, Telecom &amp; Network Security) to support/troubleshoot LAN/WAN connectivity. This may include cabling problems and/or switch to patch panel connectivity.</li>
<li>Provides technical support for numerous software systems, including the Microsoft Office Suite, Microsoft Teams, Jack Henry, Adobe, and other various financial and enterprise office environment applications.</li>
<li>Supports new installations and upgrades for both hardware and software.</li>
<li>Responsible for closing user request(s) in a timely manner.</li>
<li>Ability to work in fast paced environment and know when to escalate a problem(s) to next level support when necessary.</li>
<li>All tasks assigned by the Technology Support Manager or Technology Support Application and Software Team Lead.</li>
<li>
Maintain proficient knowledge of, and demonstrate ongoing compliance with all laws and regulations applicable to this position, ensure ongoing adherence to policies, procedures, and internal controls, and meet all training requirements in a timely manner.
</li>
<li>Performs other related duties as assigned or directed. All tasks assigned by the Technology Support Manager or Technology Support Application and Software Team Lead.</li>
</ul>
 
Qualifications
<ul>
<li>Associates Degree in MIS or business field with computer related courses or equivalent</li>
<li>Strong customer service skills and communication skills</li>
<li>Ability to work effectively in a team environment</li>
<li>Ability to multi-task in a fast paced environment</li>
<li>Working knowledge of hardware and software to facilitate technical problem solving</li>
<li>Ability to work independently and remain on task</li>
<li>Must have valid driver’s license</li>
<li>Must be able to consistently demonstrate the Company’s core values: a strong work ethic, integrity, respect for others, responsibility, transparency and humility</li>
<li>Minimum of two (2) years related experience normally required</li>
<li>Preference will be given to candidates with previous network and help desk experiences</li>
<li>All applicants must be 18 years of age or older.</li>
</ul>

Technology Support Specialist

<h3>Job Description</h3>
A highly motivated and experienced Analytical Chemist is needed to join the team. The focus of the role is the characterization of monoclonal antibodies (mAbs) and other biologics. The successful candidate will be responsible for implementing analytical methods to support the research and development of therapeutic proteins/mAbs. 
This role requires a strong understanding of protein biochemistry and a proven track record of applying a variety of analytical techniques, specifically N-glycan analysis, titer determination, Size Exclusion Chromatography (SEC), peptide mapping, imaged Capillary Isoelectric Focusing (iCE), and Capillary Gel Electrophoresis (CGE) along with some Mass Spectroscopy (MS) experience to characterize mAbs and other proteins

Scientist

<h3>Job Description</h3>
Job DescriptionSUMMARY Supervise production line operation in accordance with plant policies and procedures. Ensure smooth production operation during shift. &nbsp;PRIMARY RESPONSIBILITIES&nbsp;
<ul>
<li>Responsible for supervising and operating production lines in accordance with plant policies and procedures.&nbsp;</li>
<li>Supervise, train, and coach as necessary all general labor in conjunction with the production floor supervisor in accordance with company policies and procedures.&nbsp;</li>
<li>Responsible for quality control.</li>
<li>&nbsp;Adjust as necessary during shift to produce product within specifications.&nbsp;</li>
<li>Reject product outside of specifications.&nbsp;</li>
<li>Oversee quality of product and paperwork of on-shift production personnel.&nbsp;</li>
<li>Responsible for shift schedule to include: workstation assignments/rotations, employee training, and employee breaks.&nbsp;</li>
<li>Coordinate production startups, shutdowns, changeovers, and machine maintenance with direction from the production floor supervisor and production management.&nbsp;</li>
<li>Coordinate with Production Floor Supervisor for appropriate staffing levels.&nbsp;</li>
<li>Responsible to meet shift quality, safety, and production goals.&nbsp;</li>
<li>Operate within standard operating procedures (SOPs).&nbsp;</li>
<li>Communicate with other Lead Operators at shift changeover and Production Floor Supervisor.&nbsp;</li>
<li>Ensure a clean and safe work area. Responsible for the GDP Verification of all shift paper work &amp; daily logs; (production run sheets, quality control records, packaging requests, production reporting, etc).&nbsp;</li>
<li>Other duties as assigned. Use required Personal Protective Equipment.</li>
</ul>
ADDITIONAL RESPONSIBILITIES
<ul>
<li>Conduct quality control testing.&nbsp;</li>
<li>Perform back-up for Manufacturing/Warehouse workers when necessary.&nbsp;</li>
<li>Provide on-the-job training to all employees on a continuous basis as needed.&nbsp;</li>
<li>Extrusion of plastic tubing.</li>
</ul>
 KNOWLEDGE AND SKILL REQUIREMENTS&nbsp;
<ul>
<li>Basic reading, writing, and arithmetic skills required. This is normally acquired through a high school diploma or equivalent.&nbsp;</li>
<li>Knowledge of the manufacturing processes, procedures, and machinery. This is normally acquired through two to five years of manufacturing experience.&nbsp;</li>
<li>Manual dexterity required for operating machinery and computers.&nbsp;</li>
<li>Critical Thinking&nbsp;</li>
<li>Detail oriented&nbsp;</li>
<li>Process Improvement</li>
</ul>
2nd ShiftMonday - Friday (3:45PM – 12:15AM)
<ul>
<li>Shift ends Friday night at midnight (Saturday morning)</li>
</ul>
3rd ShiftSunday - Thursday (11:45PM – 8AM)
<ul>
<li>1st Shift starts Sunday at Midnight (Monday morning)</li>
<li>Last shift ends Friday morning at 8AM</li>
</ul>
 WORKING CONDITIONS&nbsp; Working conditions are normal for a manufacturing environment.&nbsp;

Technical Lead

<h3>Job Description</h3>
Job Description
ABOUT US: Talon.One is the most powerful incentives engine that unifies loyalty, promotions and gamification into one holistic platform. Backed by enterprise-grade security and scalability, Talon.One empowers companies to build personalized, profitable promotions and loyalty programs using any data. Today, over 250 of the world's most-loved brands including Adidas, Sephora and Carlsberg work with Talon.One to drive deeper engagement and lasting loyalty with their customers.
ABOUT THE ROLE:
Join our team as a (Senior) Technical Account Manager at Talon.One, where you'll play a key role in driving the success of our API-first promotion engine for our enterprise clients. You'll take ownership of the technical integration process, ensuring our platform fits seamlessly into each client's ecosystem. As the technical lead for your portfolio, you'll proactively monitor API usage, resolve recurring issues, and manage escalations in close collaboration with our Engineering and Customer Success teams.
You'll lead onboarding design, manage expectations, and deliver consistent value that boosts retention, growth, and satisfaction. In this strategic role, you'll also explore new tech partnerships and integration opportunities that expand our ecosystem and unlock more value for our customers.
ABOUT THE TEAM:
Our international team of 15 Technical Account Managers is spread across the world, including EMEA, US and APAC. Always striving for a seamless client onboarding and bug-less integration is what we do, and handling clients' requests is the challenge that we face on a daily level. Closely working with the Customer Success Managers and the development team is what enables us to act as consultants to all parties involved in the client onboarding journey and ultimately handling expectations related to the integration of our platform is where our value to our company lies. 
What makes us strong is our constant support for each other, our constant strive to dig deeper into problem solving, which would also be qualities we would be looking for in our next colleague as well.
This is a remote role; however, you must be located within commuting distance of one of our hubs: New York, Denver, or Boston.
ONCE YOU ARE HERE YOU WILL:
<ul>
<li>Lead the integration process of our API-driven platform with client ecosystems</li>
<li>Troubleshoot technical issues and drive resolution to prevent recurrence</li>
<li>Manage a portfolio of customers (including Enterprise accounts), focusing on API usage to ensure retention, growth, and satisfaction</li>
<li>Collaborate with Customer Success Managers and Engineering to deliver excellent client experiences</li>
<li>Identify and explore new technology partnerships and integration opportunities</li>
<li>Manage customer expectations to achieve satisfaction and success</li>
<li>Help design and improve onboarding processes</li>
<li>Work on escalated technical support tickets</li>
</ul>
WHAT WE NEED YOU TO BRING TO THE TABLE:
<ul>
<li>Several years of experience in a Technical Account Manager, Integrations Consultant, or similar role (we're open to mid-level and senior profiles)</li>
<li>Experience with API integrations, from design to implementation and ongoing support</li>
<li>Comfortable managing multiple accounts, including larger or more complex customers.</li>
<li>Experience with SaaS products</li>
<li>Strong problem-solving skills in a technical environment</li>
<li>Clear and concise communication skills, able to adapt to technical and non-technical audiences</li>
<li>Customer-focused, professional, and patient approach</li>
<li>Analytical mindset with a data-driven approach to decisions</li>
</ul>
WHAT'S IN IT FOR YOU:
<ul>
<li>$1,200 annual learning budget and full LinkedIn Learning access</li>
<li>Manage your own time off with our flexible PTO policy</li>
<li>$350 home office setup budget, a $50 monthly home office allowance</li>
<li>Freedom to work from abroad for up to 90 days worldwide!</li>
<li>WeWork On-Demand access for flexible workspace solutions </li>
<li>Mental health support with nilo.health</li>
<li>Choose from top-tier Medical, Dental, and Vision plans (Blue Cross Blue Shield MA, MetLife, VSP)</li>
<li>Build your savings with our 401(k) plan, including a 100% company match on your contributions up to 4%</li>
<li>We provide 100% company-paid Life Insurance, Short-Term, and Long-Term Disability coverage</li>
</ul>
The total compensation for this role is $85,000 - $110,000, though actual compensation may vary depending on factors such as relevant experience, skills, qualifications, certifications, and location. The salary range is subject to change and may be adjusted at any time.
WHAT WE WOULD LIKE TO LEARN FROM YOUR APPLICATION IS:
<ul>
<li>Which of the products you worked with were API-driven?</li>
<li>How extensive is your experience with API troubleshooting?</li>
<li>How much ownership have you had with clients' onboarding?</li>
<li>Who do you communicate with the most, both internally and on the client's side?</li>
</ul>
WHY YOU SHOULD WORK FOR US:
<ul>
<li>The right attitude: modern methods and a diverse, creative workspace with an open and international culture</li>
<li>Everyone for the product: Together we create a flexible, highly scalable product with state-of-the-art technologies. We can only succeed if everyone works as a team</li>
<li>Healthy Growth: Growing our company means growing everyone in the team. We love to share knowledge and learn</li>
<li>A great environment: Flexible and family-friendly environment, bright and easily accessible offices, modern software and hardware</li>
<li>High flexibility degree: Prefer to work early or late at night? Do you have to pick up your children from kindergarten? Do you prefer working abroad? We believe in results and motivated employees</li>
</ul>
Do you want this job?
We'd love to hear from you! Apply directly via the form below.
Talon.One is an Equal Employment Opportunity employer that proudly pursues and hires a diverse workforce. We do not make employment decisions on the basis of race, color, religious belief, ethnic origin, nationality, sex, gender identity, sexual orientation, disability, age, military or veteran status, or any other basis protected by applicable local, state, or federal laws or prohibited by company policy. As an employer we strive for a healthy and safe workplace and strictly prohibit harassment of any kind.
Find out more about our Candidate Privacy Policy.

(Senior) Technical Account Manager

<h3>Job Description</h3>
Job Description
Company Overview:
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We are seeking an experienced CQV and Process Engineering Consultant to support commissioning, qualification, and validation (CQV) efforts and provide technical leadership in drug product and aseptic fill-finish operations for a growing biotech client. This consulting role will contribute to facility start-up, tech transfer, and regulatory readiness activities for sterile biologics manufacturing, including mAbs, gene therapies, and other advanced modalities. 
The ideal consultant brings deep domain expertise, strong execution skills, and a collaborative mindset suited to fast-paced biotech environments. 
Key Responsibilities: 
CQV Support: 
<ul>
<li>Lead or support preparation and execution of CQV deliverables (URS, DQ, FAT/SAT, IQ, OQ, PQ) for drug product equipment and systems including: </li>
</ul>
<ul>
<li>Isolators/RABS </li>
</ul>
<ul>
<li>Aseptic filling lines (vials, syringes, cartridges) </li>
</ul>
<ul>
<li>Lyophilizers </li>
</ul>
<ul>
<li>Autoclaves, SIP/CIP systems </li>
</ul>
<ul>
<li>Cleanroom HVAC and clean utility systems (WFI, Clean Steam, Nitrogen) </li>
</ul>
<ul>
<li>Develop and apply risk-based CQV strategies (per ASTM E2500, ISPE Baseline Guides). </li>
</ul>
<ul>
<li>Review vendor documentation and support equipment start-up, troubleshooting, and deviation resolution. </li>
</ul>
<ul>
<li>Ensure compliance with client-specific and regulatory (FDA/EMA) validation standards. </li>
</ul>
Process Engineering Expertise: 
<ul>
<li>Provide hands-on technical support for sterile fill-finish operations, including drug product formulation, filtration, aseptic transfer, filling, and visual inspection. </li>
</ul>
<ul>
<li>Assist with process tech transfer from R&amp;D or CMOs to internal manufacturing, including process fit/gap analysis and scale-up readiness. </li>
</ul>
<ul>
<li>Participate in media fills, cleaning validation, and environmental monitoring strategy review. </li>
</ul>
<ul>
<li>Contribute to PPQ strategy and execution planning. </li>
</ul>
Requirements
Qualifications: 
<ul>
<li>Bachelor’s or Master’s degree in Chemical, Mechanical, or Bioprocess Engineering, or related field. </li>
</ul>
<ul>
<li>5+ years of experience in CQV and/or process engineering for sterile drug product in biotech or biopharma settings. </li>
</ul>
<ul>
<li>Demonstrated expertise with isolator systems, lyophilizers, automated filling equipment, and single-use technologies. </li>
</ul>
<ul>
<li>In-depth knowledge of GMPs, Annex 1, and phase-appropriate validation approaches for biotech drug products. </li>
</ul>
<ul>
<li>Strong documentation, project coordination, and cross-functional communication skills. </li>
</ul>
Preferred Attributes: 
<ul>
<li>Able to work independently with minimal supervision while integrating into client teams. </li>
</ul>
<ul>
<li>Flexible and adaptable to changing project scopes, priorities, and timelines. </li>
</ul>
<ul>
<li>Familiarity with electronic validation systems (e.g., Veeva, Kneat) is a plus. </li>
</ul>
Benefits
<ul>
<li>Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. </li>
<li>Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.</li>
<li>Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.</li>
</ul>
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.

Drug Product CQV Consultant

<h3>Job Description</h3>
Job Description
Who We Are: 
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 
Role Overview:
This Quality Cleaning Validation Specialist is the site SME responsible for coordinating all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the site. The position is integral to maintaining quality and safety standards in the manufacturing process, supporting both current operations and customer needs. The role is also responsible for managing the environmental and purified water monitoring programs to ensure product quality and safety throughout the manufacturing process.
Core Responsibilities: 
<ul>
<li>Contamination Control
<ul>
<li>Develop, implement, and maintain contamination control strategies and programs to ensure the protection of product quality in manufacturing environments.</li>
<li>Monitor and evaluate the effectiveness of existing contamination control systems (including air handling systems, HVAC, and microbiological controls).</li>
<li>Perform routine environmental monitoring in across manufacturing facilities to assess microbial and particulate contamination.</li>
<li>Assess, review, and improve cleaning, environmental and contamination control procedures to meet GMP, regulatory, and internal standards, including conducting risk assessments and implementation of risk mitigation strategies.</li>
<li>Establish contamination control metrics and key performance indicators (KPIs) to track and report progress against site goals.</li>
</ul>
</li>
<li>Cleaning Validation:
<ul>
<li>Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities.</li>
<li>Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants.</li>
<li>Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness.</li>
<li>Develop and maintain cleaning validation schedules to ensure timely completion of required validations</li>
<li>Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements.</li>
</ul>
</li>
<li>Environmental Monitoring &amp; Purified Water Monitoring:
<ul>
<li>Oversee and manage the environmental monitoring program, ensuring compliance with established guidelines for monitoring particulate, microbial, and endotoxin levels in manufacturing and critical areas.</li>
<li>Review and interpret environmental monitoring data and identify trends or excursions, initiating corrective actions or investigations as needed.</li>
<li>Develop and implement strategies to prevent contamination and maintain a suitable environment in manufacturing and processing areas.</li>
<li>Oversee the purified water (PW) monitoring program, ensuring compliance with quality standards for water used in pharmaceutical intermediate and API manufacturing.</li>
<li>Conduct routine sampling, testing, and analysis of purified water systems to ensure that water meets pharmacopeial standards (e.g., USP or EP) for microbial quality, endotoxin levels, and other relevant parameters.</li>
<li>Investigate and troubleshoot any deviations or issues with purified water quality, implementing corrective actions and ensuring the integrity of water systems.</li>
</ul>
</li>
<li>Compliance &amp; Documentation:
<ul>
<li>Ensure all contamination control, cleaning validation, environmental monitoring, and purified water monitoring activities are fully compliant with applicable cGMP guidelines, FDA, EMA, ICH, and other regulatory requirements.</li>
<li>Review and approve standard operating procedures related to cleaning, environmental monitoring, and water systems to ensure they meet regulatory standards.</li>
<li>Prepare and maintain detailed documentation of cleaning validation protocols, deviations, change controls, EM and PW monitoring results, and corrective and preventive actions.</li>
<li>Provide support during regulatory inspections and audits, addressing any findings or questions related to contamination control, cleaning validation, or monitoring programs.</li>
</ul>
</li>
</ul>
Qualifications: 
Required
<ul>
<li>Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field or</li>
<li>Minimum 5 years of quality assurance experience with a graduate degree in engineering, science or related field or </li>
<li>Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable)</li>
<li>Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry</li>
<li>Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems</li>
<li>Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment</li>
<li>Proficiency with risk assessment tools such as FMEA.</li>
<li>Previous experience working in cross-functional and project-based environments.</li>
<li>Experience creating metrics for driving continuous improvement</li>
<li>Excellent analytical, written and verbal communication and presentation skills</li>
<li>Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies</li>
<li>The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently</li>
<li>Experience in a fast-paced work environment</li>
<li>Certification in contamination control (e.g., PDA Certification in Contamination Control).</li>
<li>Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9)</li>
<li>Experience with continuous improvement methodologies such as Lean or Six Sigma desire</li>
<li>Familiarity with environmental monitoring equipment and purified water system design and validation</li>
<li>Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation</li>
</ul>
Our Commitment:
<ul>
<li>Health &amp; Wellness: Comprehensive health &amp; Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. </li>
<li>Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.</li>
<li>Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.</li>
<li>Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.</li>
</ul>
How to Apply: 
At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit <a href="http://www.veranova.com" target="_blank">www.veranova.com</a> to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. 
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. 
If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to <a href="mailto:talentacquisition@veranova.com" target="_blank">talentacquisition@veranova.com</a> in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 
Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.
<ul>
<li>Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.</li>
<li>Legitimate LinkedIn communications will only come from active Veranova employees.</li>
<li>Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).</li>
<li>Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).</li>
</ul>
If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: <a href="mailto:pharm.hr@veranova.com" target="_blank">pharm.hr@veranova.com</a> (US) or <a href="mailto:UKHR@veranova.com" target="_blank">UKHR@veranova.com</a> (UK).
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Quality Cleaning Validation Specialist

<h3>Job Description</h3>
Job Description
Join the Innovation Engine at Advanced Instruments, a part of Nova Biomedical
 At Advanced Instruments, now proudly part of Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. As a global leader in analytical technologies for the biopharmaceutical and clinical markets, our solutions are trusted in over 100 countries to accelerate drug development and enhance patient care.
Together, we are united by a bold vision: to improve the health of every patient through innovation and excellence. Our mission is to deliver smart, science-driven solutions that optimize processes, increase efficiency, and ensure confidence in results—ultimately leading to better outcomes for patients and providers alike.
Our integration brings together over 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. From FDA-registered, ISO-certified manufacturing to 125+ FDA approvals and industry-trusted diagnostics, we set the standard for quality and reliability. Advanced Instruments is also the global leader in osmolality testing, with a legacy of innovation that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a growing global presence of 1,965 employees, we’re building an empowered, collaborative culture grounded in our shared values: Customer Centricity, Ingenuity, Ownership &amp; Accountability, Collaboration, and Integrity. We’re honoring our founder led legacies—and shaping a future defined by impact.
Explore what’s next with us at <a href="http://www.novabiomedical.com" target="_blank">http://www.novabiomedical.com</a> or <a href="https://www.aicompanies.com" target="_blank">https://www.aicompanies.com</a>
 
About the role
 
Tier 3 Technical Support Specialist is a customer facing resource responsible for escalated phone and email support to customers using Advanced Instruments’ (Osmo, Solentim, Artel) products. You will need to have a strong technical understanding to help diagnose intricate issues and assist with a customer’s overall satisfaction by finding a quick resolution/resolution plan. You will also provide exemplar customer service to provide the best outcomes.
 
What we are looking for in you
 
<ul>
<li>Specialization in one or more instruments/processes (ie: Artel, Solentim, Osmo, Legacy Instruments, New Releases, Networking, Distributors, Documentation, etc)</li>
<li>Provide in depth technical support for clients focusing on troubleshooting complex issues</li>
<li>Ability to create action plans for customer issues</li>
<li>Work with other departments on customer issues and to create best practices for future issues</li>
<li>Strong technical case documentation ability in accordance with medical device industry requirements and our company’s standard of excellence </li>
<li>Excellent problem solving and troubleshooting skills</li>
<li>Proficient attention-to-detail and follow-up skills; customer-focused and results-oriented attitude</li>
<li>Strong oral and written communications skills</li>
<li>Collaborate with Tier 1 to ensure quotes are generated and customer information is accurate</li>
</ul>
 
Qualifications 
<ul>
<li>Experience with durable goods manufacturing technologies and industry-specific software platforms</li>
<li>Certifications such as CompTIA A+, Network+, or Microsoft Certified Solutions Expert (MCSE)</li>
<li>Familiarity with PLC programming, SCADA systems, and industrial automation protocols</li>
<li>Prior experience in mentoring or leading technical support teams</li>
<li>Knowledge of ITIL framework and best practices in technical support service management</li>
<li>Ability to commute to Norwood office, three days a week</li>
</ul>
 
What's in it for you?
<ul>
<li>Flexible Medical, Dental, &amp; Vision Coverage</li>
<li>Competitive 401k company match</li>
<li>Bonus Program, Generous PTO and paid holidays</li>
<li>Generous Tuition reimbursement</li>
<li>Professional development, engagement and events</li>
<li>Company marketplace for lunch and snacks!</li>
</ul>
EEO Statement:
Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Privacy policy
<a href="https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW" target="_blank">https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW</a>

Tier 3 Technical Support Specialist

<h3>Job Description</h3>
Job DescriptionJob Summary
In this role, you’ll lead cross-functional projects that enhance marketing systems, streamline processes, and improve team performance. You’ll collaborate closely with stakeholders across marketing, product, and tech to ensure initiatives are delivered on time, within scope, and aligned with business goals. This is a high-impact role for a systems thinker who thrives in fast-paced environments, excels at cross-team collaboration, and loves building order out of complexity.
 Duties and Responsibilities
Project and Process Management&nbsp;
<ul>
<li>Drive marketing-related tech initiatives from planning through execution, including platform optimization, martech stack improvements, campaign workflow automation, and internal tool integrations.</li>
<li>Define project scopes, create timelines, assign owners, and track milestones to ensure timely delivery.</li>
<li>Identify and implement process improvements that enhance team agility, content production, campaign execution, or data flow.</li>
<li>Own SOP documentation and rollout plans for new platforms, features, or process changes across the marketing organization.</li>
</ul>
Cross Functional Collaboration&nbsp;
<ul>
<li>Serve as a bridge between marketing and technical teams (e.g., engineering, data, product), translating marketing needs into executable projects.</li>
<li>Coordinate cross-functional input and resources for integrated marketing campaigns, tool adoption, or infrastructure changes.</li>
<li>Maintain clear communication and project updates with all stakeholders, proactively identifying roadblocks and aligning on solutions.</li>
</ul>
Data and Reporting&nbsp;
<ul>
<li>Monitor and report on key metrics related to marketing project impact (e.g., campaign delivery times, tool adoption rates, lead throughput).</li>
<li>Conduct post-project retrospectives to identify learnings and recommend optimizations.</li>
<li>Partner with analytics and ops to improve visibility into marketing performance through dashboards and automation.</li>
<li>Maintain and manage tools such as ClickUp, Asana, or Notion to track project progress and team bandwidth.</li>
</ul>
Skills and Abilities&nbsp;
<ul>
<li>3–5 years of experience in project management, marketing operations, or a similar role supporting cross-functional teams.</li>
<li>PMP Certification is preferred </li>
<li>Demonstrated ability to lead complex projects that involve both technical and non-technical stakeholders. </li>
<li>Familiarity with marketing technologies and workflows (CRM, CMS, marketing automation, analytics platforms).</li>
<li>Exceptional organizational skills and attention to detail; skilled at prioritizing work and managing timelines across multiple projects.</li>
<li>Strong written and verbal communication skills; comfortable managing up, across, and down.</li>
<li>Proficiency in project management tools such as Asana, ClickUp, or Monday.com.</li>
<li>Passion for marketing efficiency, collaboration, and operational excellence.</li>
<li>Bonus:Working knowledge of DTC and e-commerce marketing models.</li>
</ul>
 This is a remote position.&nbsp;
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