Cleaning Validation Engineer

Our client is a global leader in medicine, recognized for innovation and excellence in injectable products.

Description

• Provide expert support on cleaning validation activities (protocols, reports, investigations, strategies).
• Review and approve validation documentation (URS, protocols, reports, acceptance limits).
• Advise on best practices and regulatory standards (ISO, FDA, EMA, PIC/S).
• Support resolution of deviations, CAPA, and compliance issues.
• Design and deliver a comprehensive training program for internal teams.
• Develop training materials and supervise practical implementation on-site.
• Evaluate team competency and ensure full autonomy post-mission.
• Conduct critical review of existing SOPs, strategies, and historical reports.
• Identify opportunities for process simplification and standardization, and propose process improvements.

Profile

• Degree in Chemical Engineering, Biotechnology, Pharmacy.
• Minimum 5 years of experience in cleaning validation within pharma or sterile medical devices.
• Strong knowledge of GMP, FDA, and EU regulatory frameworks.
• Expertise in analytical techniques (TOC, HPLC, gravimetry) and risk-based approaches (MACO, PDE).
• Demonstrated ability to train and coach multidisciplinary teams with pedagogical skills.
• Skilled in challenging existing practices and proposing pragmatic solutions.
• Fluent in English, French is an asset.

Job Offer

• Work on a high-impact project shaping compliance and operational excellence.
• High-impact expert role in a global organization.
• Opportunity to lead strategic compliance and training initiatives.