Sterilization Equipment Operator in Industry (M/F)

To support our growth and the development of new projects, we are looking for a Gamma Sterilization Validation Engineer M/F for our client in the Life Sciences sector.

Your Missions:

Analyze customer needs, draft the Validation Master Plan (VMP) and the User Requirement Specifications (URS) for sterilization processes. Define and implement qualification / validation strategies (DQ, IQ, OQ, PQ) in accordance with ISO 11137, ISO 13485, GMP, FDA 21 CFR Part 820 standards. Lead dose mapping and dose distribution studies (dose maps, dose audits, half-cycle, bioburden). Coordinate stakeholders: equipment suppliers (irradiators, ETO chambers), QA teams, production, HSE, and regulatory authorities. Implement the periodic monitoring plan (requalification, revalidation) and ensure the monitoring of performance indicators. Manage technical documentation: protocols, reports, contamination control plans, risk analyses (FMEA, HACCx.). Participate in internal/external audits (ANSM, FDA, clients) and regulatory inspections. Contribute to continuous improvement, team training, and technological monitoring of sterilization processes.

Your Profile:

Engineer or Master 2 in process engineering, pharmacy, chemistry, biotechnology, or equivalent. 3 to 5 years of experience in Gamma sterilization process validation in the healthcare industry. Mastery of ISO 11137, ISO 13485, GMP, 21 CFR Part 210/211 & 820 standards. Knowledge of quality / risk management tools (FMEA, HACCP, AMDEC, etc.). Strong writing skills, analytical mind, documentary rigor. Fluent professional English (supplier exchanges & regulatory files). Team spirit, leadership, and communication skills.

This job offer is open to all profiles.