Job Description
Job Description
Job Summary:
The Process Validation Engineer is responsible for planning, executing, and documenting process validation activities to ensure that manufacturing processes consistently produce products meeting quality and regulatory requirements (FDA, GMP, ISO 13485). The role involves working cross-functionally with Manufacturing, Quality, and R&D teams to support new product introductions, process improvements, and ongoing validation maintenance.
Key Responsibilities:
- Develop and execute Process Validation (PV) protocols (IQ/OQ/PQ) in compliance with regulatory standards.
- Support Equipment Qualification and Cleaning Validation as needed.
- Conduct risk assessments (FMEA) and establish critical process parameters and acceptance criteria.
- Perform data analysis and summarize validation results with clear conclusions and recommendations.
- Prepare and maintain validation documentation, reports, and master plans.
- Collaborate with manufacturing and quality teams to identify and resolve process issues.
- Ensure compliance with cGMP, FDA, ISO 13485, and company validation policies.
- Support change control and CAPA processes related to validated systems.
- Participate in internal and external audits by providing validation documentation and responses.
Required Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or equivalent.
- 3 years of experience in process validation within the pharmaceutical or medical device industry.
- Strong knowledge of cGMP, FDA 21 CFR Part 820, and ISO 13485 regulations.
- Hands-on experience with validation protocols, test execution, and statistical analysis.
- Proficiency in tools like Minitab, Excel, or other data analysis software.
- Excellent technical writing, communication, and organizational skills.
Thanks
Suchi
Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.
Company Description
Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.