Manager, Commissioning & Qualification - Engineering

Gaithersburg, US   |   full time   |   Job ID: 8842 

The Commissioning & Qualification Manager will lead and guides validation efforts, including the development and maintenance of the site Validation Master Plan of the site.  Key responsibilities involve leading the creation and execution of commissioning, qualification, and validation protocols (CP/IQ/OQ), as well as addressing exceptional conditions in equipment, facilities, utilities, and systems. The role also includes managing Computerized System Validation (CSV) efforts of the site. The Commissioning & Qualification Manager will provide oversight, lead execution and work cross-functionally and in project teams to determine the extent of validation required for the implementation of new assets, conduct impact assessments for proposed changes to existing assets, and be responsible for the execution of BioNTech GB site re-qualification program.

Primary Responsibilities:

• Oversee the planning, execution, and documentation of validation activities for equipment, systems, instruments, and computerized systems for GMP operations.
• Owns and maintains a robust qualification and quality program to support and maintain in a qualified and compliance state the facility, including process, laboratories and utilities equipment.  
• Approve, review and generate as needed commissioning, qualification, and validation (CQV) protocols (CP/IQ/OQ/PQ), recognizing specific parameters, sampling and tests, including identification and resolution of exceptional conditions of equipment, facilities, utilities and systems.
• Approve, review and generate technical documentation as needed including specifications, lifecycle documentation and validation SOPs.
• Ensure validation protocols and processes comply with global regulatory requirements. Correctly employ industry best practices that will withstand regulatory inspections by regulatory authorities.
• Assists in equipment selection, specification, and the application of a risk-based approach when determining qualification strategies.
• Ensure compliance with Computerized System Validation (CSV) requirements and documentation such as Risk Assessments, Validation Project Plans, User Acceptance Tests and Reports etc.
• Guide and lead temperature mapping and other miscellaneous validation activities.
• Lead and mentor the validation team, fostering a culture of excellence and continuous improvement.
• Manage contractors supporting CQV and CSV activities.
• Support process and method transfer validation activities, as necessary by manufacturing and Quality Control labs.
• Participates in internal audit/inspection
• Conduct risk assessments and develop mitigation strategies for validation projects.
• Develop and implement validation strategies and policies in alignment with regulatory requirements and company goals.
• Other Duties as assigned.

Requirements: 

• Minimum requirements include a bachelor’s degree in a technical, preferably an engineering or biological science discipline and 10+ years pharmaceutical and/or biopharmaceutical industry experience or MS degree in a technical, preferably an engineering or biological science discipl