We are seeking a Quality Control CQV Engineer to support the implementation and lifecycle management of computerized systems within a GMP-regulated pharmaceutical/biotech environment. This role is responsible for ensuring that QC laboratory systems and standalone equipment are properly installed, qualified, and maintained in compliance with regulatory and data integrity requirements. The ideal candidate will work both independently and cross-functionally to deliver validation activities from initiation through completion.
Key Responsibilities
- Set up computerized systems (e.g., Empower, standalone PCs, standalone equipment)
- Qualify computerized systems in accordance with validation requirements
- Draft, review, approve, and execute validation protocols (via Kneat and/or hardcopy)
- Prepare and approve validation documents in Kneat and/or Document Management Systems (e.g., Documentum)
- Draft and revise system configuration SOPs
- Initiate, manage, and close out change controls and assigned tasks
- Coordinate with vendors to perform IOQ (Installation and Operational Qualification) activities
- Liaise with QC and project leads on validation execution activities and deliverables
- Perform routine activities such as user access management and audit trail reviews
- Plan validation timelines and, where required, lead projects to ensure end-to-end completion of validation workflows
- Operate in a highly independent role with minimal supervision
Requirements
- Bachelor's degree in a relevant field with prior experience in biotech/pharma manufacturing
- Strong GMP knowledge and documentation experience
- Strong problem-solving and analytical skills
