Operational Technology Manager

Job Description

Job Description

Position Summary

The Manager of Operational Technology (OT) is responsible for leading the development, integration, and lifecycle management of operational technology systems at Sharp Sterile. This role is crucial in ensuring the security, integrity, and performance of systems that directly support GMP operations, including SCADA, PLCs, BMS, EMS, MES, data historians, and other critical control and monitoring technologies. The OT Manager will act as a bridge between IT, engineering, and manufacturing to ensure optimal system performance, regulatory compliance (FDA, EU GMP, etc.), and digital transformation across the plant.

Duties and Responsibilities

Operational Technology Strategy & Oversight

• Develop and execute the OT roadmap aligned with the company’s digital and operational goals
• Oversee the design, implementation, and maintenance of OT infrastructure and software systems supporting GMP manufacturing, aseptic filling, utilities, and labs
• Partner with IT and CSV to manage GxP system backups and disaster recovery procedures
• Ensure 24/7 uptime of critical OT systems supporting sterile operations

System Integration & Lifecycle Management

• Manage and maintain SCADA, PLCs, MES, EMS/BMS, and other automation platforms
• Lead OT change control, validation, and qualification processes in alignment with GAMP 5 and FDA 21 CFR Part 11
• Partner with IT on network segmentation, cybersecurity, patch management, and disaster recovery for OT assets

Compliance & Quality Assurance

• Ensure OT systems comply with GMP regulations and internal quality standards
• Own and maintain system documentation, including URS, FRS, validation protocols (IQ/OQ/PQ), SOPs, and risk assessments
• Participate in internal and external audits, supporting data integrity, access controls, and audit trails

Cross-Functional Leadership

• Collaborate with Manufacturing, Quality, Engineering, and IT teams to ensure OT solutions meet operational needs
• Lead and develop a small team of OT/automation engineers and contractors
• Act as the OT SME for client tech transfers, investigations, and process changes

Innovation & Continuous Improvement

• Identify and implement OT-based improvements to increase efficiency, reduce downtime, and enable data-driven decision-making

Evaluate emerging technologies (e.g., advanced analytics, digital twins, IIoT) for potential application in a GMP environment

Regulatory Responsibilities

• Ensure all work is performed in accordance with current regulatory requirements and internal SOPs
• Support data integrity initiatives and provide input to compliance metrics

Supervisory Responsibilities

• Collaborate with various departments, including engineering, production, quality assurance, and supply chain, to ensure project requirements are met and to resolve any technical challenges
• Coordinate tasks to support manufacturing schedules and priority projects

Experience

• Five plus (5+) years of experience in OT/automation systems in a GMP-regulated pharmaceutical or biotech manufacturing environment
• Experience managing and mentoring technical staff and/or contractors
• Experience working in a CDMO environment preferred

Education

• Bachelor’s degree in Engineering, Computer Science, Information Systems or a related field is desired or equivalent experience in the industry

Knowledge, Skills & Abilities

• Familiarity with Microsoft Active Directory, DNS and DHCP
• Familiarity of local area networking and WiFi
• Good understanding and awareness of Cybersecurity policies and best practices
• Proficiency with OT platforms such as PLC/SCADA (Siemens, Rockwell), MES (Werum, Emerson Syncade, etc.), BMS/EMS (Johnson Controls, Honeywell), and data historians (OSIsoft PI)
• Deep understanding of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles
• Familiarity with ISA-95/ISA-99, NIST cybersecurity framework, or similar OT standards preferred
• Experience with digitalization or Industry 4.0 initiatives preferred
• Excellent communication, interpersonal and leadership skills
• Strong problem-solving and analytical abilities
• Cross-functional collaboration with technical and non-technical stakeholders.
• Strategic thinking with hands-on troubleshooting capability
• Exceptional organizational and documentation skills
• On-site role in a GMP manufacturing environment
• May require off-hours support during shutdowns or critical system events
• Occasional travel for training, audits, or vendor interactions

Physical Requirements

• Ability to sit for prolonged periods of time
• Ability to lift up to 50lbs
• Ability to stand for prolonged periods of time