Process & Cleaning Validation Consultants (Biopharma)
Contract: 6-12 months
Locations: France, Belgium, Netherlands (multiple sites)
Engagement Type: Hybrid or On-Site (depending on project and client requirements)
Eligibility: Candidates must have valid right to work in the EU (no sponsorship available)
Overview
We are partnering with a major biopharmaceutical client experiencing a significant increase in demand for Process Validation and Cleaning Validation expertise across multiple European manufacturing sites.
We are therefore seeking experienced Process & Cleaning Validation Consultants with strong technical capabilities in large-scale biologics manufacturing environments.
This is a unique opportunity to contribute to high-impact projects supporting commercial and late-stage biologics programs, with flexibility in location and working model.
Key Responsibilities
Process Validation (Drug Substance)
- Lead and support process validation activities for large-scale mammalian or microbial drug substance manufacturing
- Develop and execute Process Performance Qualification (PPQ) protocols
- Author and review validation documentation (protocols, reports, risk assessments)
- Perform process risk assessments and define CPPs and CQAs
- Support technology transfer and scale-up activities
- Collaborate cross-functionally with MSAT, Manufacturing, QA, and Regulatory teams
Cleaning Validation / Utilities
- Develop and implement cleaning validation strategies across production and utility systems
- Define acceptance criteria based on toxicological and product-based limits
- Author cleaning validation protocols and reports
- Support validation of CIP/SIP systems and clean utilities (e.g., purified water, WFI)
- Perform risk assessments and worst-case product selection
- Ensure compliance with current GMP and regulatory expectations
Candidate Profile
Required Experience
- Experience in process validation for biologics drug substance
- Background in large-scale mammalian or microbial manufacturing processes
- Exposure to cleaning validation within GMP-regulated environments
- Strong understanding of validation lifecycle and documentation (IQ/OQ/PQ/PPQ)
Preferred Skills
- Experience across multiple manufacturing sites or consultancy environments
- Familiarity with European regulatory requirements (EMA, Annex 15, etc.)
- Exposure to utilities validation (WFI, clean steam, CIP/SIP)
Language Skills
- French language capability is highly desirable (a strong advantage for several sites)
- Fluency in English required
Flexibility on Profiles
We recognise that not every candidate will meet every requirement listed above. We are open to discussing professionals who bring a strong foundation in either process validation or cleaning validation, even if they do not tick every box.
If your experience is closely aligned and you are operating within the biopharma validation space, we would be very interested in exploring your profile further.
Working Model
- Hybrid or fully on-site depending on project needs
- Opportunities across France, Belgium, and the Netherlands
- Some flexibility for travel between sites may be beneficial
Why Join
- Work with a leading biopharma client on high-visibility projects
- Access to multiple opportunities across European manufacturing sites
- Opportunity to apply and broaden expertise across process and cleaning validation
- Dynamic project environment with immediate impact