Quality Engineering Manager

A growing biopharmaceutical company is seeking a Quality Engineering Manager to support commissioning, qualification, and validation (CQV) of GMP manufacturing and testing equipment. The successful candidate will provide quality oversight of equipment lifecycle management and process validation activities, ensuring industry best practices and regulatory compliance.

Responsibilities

Draft, review, and update procedural documents (SOPs, protocols, test methods).

Oversee qualification activities for facilities, equipment, and instruments.

Interface with cross-functional departments to plan and execute CQV activities.

Review and approve validation master plans, URS, executed protocols, and reports.

Support metrology program, calibration activities, and cleaning validation processes.

Lead deviation and CAPA investigations related to CQV.

Maintain documentation in EDMS (e.g., Veeva QualityDocs) and asset tracking systems.

Requirements

Bachelor’s degree in a science-related field.

8+ years of experience in the pharmaceutical or biotech industry with increasing responsibility in CQV.

Minimum 3 years in a GMP manufacturing setting.

Solid understanding of GMP and / or GLP regulations.

Preferred

Advanced degree.

Certifications such as CQA or CQMP.

Experience with electronic document management systems.