GMP Cleaning Validation Lead – On-Site in Toulouse
TOULOUSE, 31
il y a 1 jour
Work Place: On-Site, Toulouse
Project Duration: 18 MonthsLanguages: Fluent French & English Required
No visa sponsorship available
OverviewWe are seeking an experienced Cleaning Validation Consultant to support a high-profile, large-scale pharmaceutical manufacturing facility. This is a full-time, on-site role within a GMP-regulated environment, focused on ensuring compliance and robustness of cleaning processes across production.
Key Responsibilities- Lead and execute cleaning validation activities across manufacturing equipment and systems
- Develop, write, and execute validation protocols and reports (IQ/OQ/PQ)
- Perform and review residue limit calculations (MACO) and cleaning acceptance criteria
- Support implementation and optimisation of CIP/SIP cleaning processes
- Collaborate closely with QA, QC, Production, and Engineering teams
- Provide subject matter expertise during regulatory inspections and audits (FDA, EMA)
- Ensure all documentation complies with GMP standards and internal quality requirements
- Troubleshoot validation issues and provide practical, compliant solutions
- Strong experience in cleaning validation within pharmaceutical or biotech environments
- Proven track record working in GMP-regulated settings
- Hands-on expertise in protocol writing and execution (IQ/OQ/PQ)
- Solid understanding of analytical methods , including TOC and HPLC
- Experience with MACO calculations and contamination control strategies
- Familiarity with equipment cleaning processes in manufacturing environments
- Experience supporting health authority inspections (FDA, EMA)
- Ability to work effectively in cross-functional teams
- Strong documentation, communication, and stakeholder management skills
- Fluent French (essential)
- Fluent English (essential)
- This role is 100% on-site at a major pharmaceutical manufacturing facility
- Candidates must have the right to work in the location - no sponsorship is available
Entreprise
EPM Scientific
Plateforme de publication
WHATJOBS
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