QA Validation Manager, Manufacturing Equipment

5 months ago


Vancouver, Canada AbCellera Full time

AbCellera is in search of a QA Validation Manager for cGMP manufacturing equipment who can lead quality oversight of validation activities and/or execute QA validation deliverables for these areas.

The position provides guidance and hands-on support for multiple, complex validation projects, ensuring all qualification and validation activities adhere to regulatory requirements, industry standards, and the AbCellera Site Validation Master Plan and associated procedures.

**We'd love to hear from you if**
- You are a passionate leader who can motivate, inspire, and build highly effective teams while managing for high performance and the development of others.
- You have management experience overseeing validation activities for manufacturing equipment, work well within cross-functional teams, and have experience providing QA oversight and support for the planning of commissioning, qualification, and validation activities.

**How you might spend your days**
- Leading and nurturing the QA Validation team for facilities and equipment.
- Establishing and maintaining high-quality validation processes aligned with regulations.
- Collaborating with vendors for troubleshooting and data leverage in facilities and utilities validation.
- Playing a key role in creating vital validation documentation for CQV projects.
- Developing, reviewing and endorsing commissioning and qualification documents and ensuring inspection readiness.

**Qualifications**
- BS or equivalent degree, preferably in Sciences or Engineering.
- 8+ years experience in Biotech/Pharmaceutical industry, with Quality Compliance or QA Validation background.
- Proficiency in GCP, GMP, GDP, and GLP.
- Strong knowledge of ISPE Baseline Guide Vol 5, ISPE GAMP 5.
- Familiarity with standards: USP, ANSI, ISO, ASTM, OHSA.
- Expertise in data governance/integrity, including 21 CFR Part 11, Annex 11, FDA Draft Guidance.
- Experience in creating, reviewing, and approving validation documentation.
- Demonstrated critical thinking and risk-based decision-making.
- Excellent oral and written communication skills, including constructive challenges and issue resolution.
- Experience with standard equipment for biological products, including Single-Use bioreactors, chromatography columns, freezers, cryofreezers, isolators, and autoclaves.



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