CQV Engineer
il y a 1 jour
CQV Engineer – Manufacturing Equipment (Biologics)
Location:
Occitanie France
Contract Type:
Freelance
Onsite Requirement:
Full-time, 5 days per week
Start Date:
ASAP
Duration:
12 months
Role Overview
The CQV Engineer will act as
system owner for manufacturing equipment
, ensuring equipment is qualified and ready for operational handover. The scope centres on
manufacturing systems used in upstream and downstream production
, with responsibility for protocol review and approval, commissioning support and qualification oversight.
Key Responsibilities
- Lead and own qualification of manufacturing equipment such as bioreactors, vessels, dryers, chromatography systems, filtration systems and autoclaves
- Review and approve IQ/OQ/PQ protocols prepared by validation teams and execution owners (no protocol writing or protocol execution expected)
- Provide technical oversight during commissioning and qualification to ensure equipment functionality aligns with process requirements
- Verify correct implementation of control strategies, operating ranges and alarm/limit settings prior to manufacturing use
- Troubleshoot equipment-related CQV gaps and ensure rapid resolution prior to operational handover
- Maintain alignment between CQV activities, GMP expectations and production timelines
Required Experience
- Approximately 10 years' experience working with CQV or validation of
biologics manufacturing equipment - Expert knowledge of how manufacturing equipment functions at the operational level
- Experience reviewing and approving validation protocols in a GMP environment
- Ability to act as technical system owner without executing qualification protocols directly
- Background in biotech/pharmaceutical production environments (not facility/utilities CQV)
- Fluent English required
This position requires a professional who can represent Operations, Quality and Engineering from a system-ownership perspective and ensure equipment is fully compliant and fit for commercial manufacturing.
Candidates available immediately or on a short notice period will be prioritised.
To discuss the assignment or apply, please reach out with your latest CV.
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