CQV Engineer

il y a 21 heures

Toulouse, Occitanie, France Optimus Search Temps plein

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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