Senior QA Engineer, Validation

About the role

The Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and approves QA validation activities and documents associated with decommissioning, new or modified systems as well as maintenance of the validated state of equipment, processes, and systems. Occasional opportunities for international and/or domestic travel may be available for this role.

Responsibilities

• Serves as QA CQV subject matter expert (SME) with regulators, clients, and company management.
• Affirms the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
• Oversees and approves system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process, and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Develops, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities, and equipment.
• Ensures the completion of project and operational quality objectives within desired timelines.
• Provides manufacturing (Clean Room) shop floor support for issue resolution, as needed.
• Participates in optimization or improvement initiatives.
• Supports regulatory agencies and third-party inspections.
• Shares knowledge and mentors less experienced team members by providing technical guidance on QA validation activities.
• Performs other duties, as assigned.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 8+ years of applicable industry experience; OR, Master’s degree in Life Sciences or Engineering with 6+ years of applicable industry experience; OR; PhD in Life Sciences or Engineering with 4+ years of applicable industry experience.
• 4+ years of experience working in a GMP regulated environment.
• Experience in Commissioning, Qualification, and Validation (CQV) and Quality oversight, in an FDA regulated facility.