Cleaning Validation Engineer

Our client seeks an experienced Cleaning Validation Expert for a 6-month mission in order to support the validation activities, strengthen internal capabilities, and optimize the robustness of the cleaning processes. You will provide technical leadership, training, and process optimization to strengthen compliance and operational excellence.

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.

jida521f05afr jit1147afr jpiy25afr