CQV Engineer
Katalyst CRO · Dexter, MI · 1 mo ago
On-siteEngineeringContract
Responsibilities
- Act as System Owner for assigned equipment within Bulk or Fill Finish areas.
- Participate in design reviews and ensure alignment with URS and GMP requirements.
- Lead and/or support development of GxP documentation (URS, SRA, DQ, RTM, protocols).
- Support commissioning and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable).
- Manage and track system deliverables in line with project schedule.
- Cookordination with CQV, Engineering, Automation, QA, and Construction teams.
- Identify and manage risks, issues, and dependencies related to assigned systems.
- Support verification planning aligned to ASTM E2500 methodology.
- Ensure systems are ready for handover to validation/operations.
Requirements
- 47 years' experience within CQV / Process Engineering in GMP environments.
- Hands-on experience with system ownership and equipment qualification.
- Strong understanding of CQV lifecycle and GxP documentation.
- Experience working on large CAPEX or GMP manufacturing projects.
- Familiarity with ASTM E2500 / risk-based qualification approaches (preferred).
- Ability to work in a cross-functional, fast-paced project environment.
- Familiarity with KneTelecommunicationrade; (electronic CQV documentation platform) is a nice to have.