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QA Validation Manager, Manufacturing Equipment

AbCellera Biologics

AbCellera Biologics

Quality Assurance
Vancouver, BC, Canada
Posted on Friday, August 11, 2023

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  • Expertise in data governance/integrity, including 21 CFR Part 11, Annex 11, FDA Draft Guidance.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.