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Expleo

End-to-end engineering, tech consulting, quality services

Ingénieur Commissioning Qualification

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRouen, France

About the Job

Requirements

  • A BAC+5 qualification in general engineering, processes, or production/utilities is required.
  • At least five years of experience with equipment is required.
  • Knowledge of the pharmaceutical sector is strongly appreciated.
  • Knowledge of pharmaceutical regulatory constraints, including BPF, BPD, GMP, and 21 CFR Part 11, is required.
  • Mastery of the V-cycle is essential.
  • Technical English is an advantage.
  • Analytical thinking, rigor, and interpersonal ease are expected.

Responsibilities

  • Participate in design reviews of systems.
  • Review supplier FAT protocols for system consistency with the functional analysis conclusions.
  • Complete supplier SATs.
  • Receive and commission equipment through FAT/SAT.
  • Participate in writing risk analyses and criticality analyses.
  • Write the qualification master plan, defining the methodology and strategy to deploy for the relevant system.
  • Write and execute IQ, OQ, and PQ protocols.
  • Track nonconformities and associated corrective actions.
  • Write qualification reports.
  • Assess the specific equipment required to carry out C&Q tests.
  • Train testers on the protocols for tests to be performed.
  • Plan and coordinate testers and support-service interventions.
  • Write the validation master plan, defining the methodology and strategy to deploy for the relevant system.
  • Write and execute validation protocols in collaboration with production.
  • Write validation reports.
  • Make occasional trips, including to suppliers in France or internationally.

Desired Qualifications

  • Knowledge of the pharmaceutical sector.
  • Technical English proficiency.

About the Company

Expleo

End-to-end engineering, tech consulting, quality services

Expleo provides end-to-end engineering, technology consulting, and quality services to help businesses with digital transformation. It combines software quality assurance and testing with engineering and R&D capabilities to design, build, test, deploy, and maintain software-enabled and engineered systems. It stands out by integrating software quality expertise with broader engineering and digital-transformation offerings under one umbrella for industries like banking and telecommunications. Its goal is to help organizations navigate digital transformation by delivering reliable, efficient, and scalable software and systems.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Montigny-le-Bretonneux, France
Founded
1966

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