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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, process engineering, production, or 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 requirements, including BPF, BPD, GMP, and 21 CFR Part 11, is required.
  • Mastery of the V-cycle is imperative.
  • Technical English is a plus.
  • Analytical thinking, rigor, and interpersonal ease are expected.

Responsibilities

  • Participate in the design review of systems.
  • Review supplier FAT protocols for systems and verify their consistency with the functional analysis conclusions.
  • Complete supplier SATs.
  • Receive and commission equipment through FAT/SAT.
  • Participate in drafting risk analyses and criticality analyses.
  • Draft the qualification master plan, setting out the methodology and strategy for the system.
  • Draft and execute IQ, OQ, and PQ protocols.
  • Track non-conformities and associated corrective actions.
  • Draft qualification reports.
  • Assess the need for specific materials to conduct C&Q tests.
  • Train testers on the protocols for the tests to be performed.
  • Plan and coordinate testers and support-service interventions.
  • Draft the validation master plan, setting out the methodology and strategy for the system.
  • Draft and execute validation protocols in collaboration with production.
  • Draft validation reports.

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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