Cleaning Validation Engineer

About

You will play a key role in ensuring robust contamination control strategies and compliance with GMP requirements across equipment and manufacturing processes.

Key Information

• Location: Basel region, Switzerland (on-site)
• Contract: Consulting assignment
• Start date: ASAP
• Experience: 3–5+ years in Cleaning Validation / QA Validation
• Industry: Pharma / Biotech (GMP environment)
• Languages: German mandatory, English required

Your Role

You will lead and support Cleaning Validation activities for manufacturing equipment and processes, ensuring full compliance with regulatory standards and internal quality requirements.

Key Responsibilities

• Develop, review and execute Cleaning Validation protocols and reports
• Define validation strategies, risk assessments and sampling plans
• Establish and justify acceptance criteria (MACO, HBEL, carryover limits)
• Perform risk assessments (FMEA) and support deviation investigations and change controls
• Support and review CIP/SIP system validation and qualification activities
• Collaborate with QA, Production, Engineering and QC teams
• Ensure compliance with EU GMP Annex 15, FDA guidelines and internal standards

Your Profile

• Degree in Pharmaceutical Sciences, Chemistry, Biotechnology or Engineering
• 3–5+ years’ experience in Cleaning Validation or QA Validation in pharma/biotech
• Strong knowledge of GMP regulations (EU / FDA)
• Experience with CIP/SIP systems and/or equipment qualification is a strong plus
• Ability to write and review GMP documentation (protocols, reports, CAPAs, deviations)
• Analytical mindset and structured working approach
• German mandatory (spoken and written), English professional level

Why This Role

• Exposure to a high-standard GMP manufacturing environment
• Key role in contamination control and validation strategy
• Strong cross-functional collaboration
• Long-term project visibility

Keywords

Cleaning Validation, GMP, CIP, SIP, Validation Engineer, Pharma Manufacturing, Contamination Control, MACO, HBEL

Process

Confidential recruitment process with response within 48 hours.

Immediate need – priority given to relevant applications.