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Expleo

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

Ingénieur C&Q

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

About the Job

Requirements

  • A Master’s-level engineering education in general engineering, process engineering, or production/utilities is required.
  • At least five years of experience with equipment is required.
  • Knowledge of the pharmaceutical sector is strongly appreciated.
  • Mastery of pharmaceutical regulatory requirements, including BPF, BPD, GMP, and 21 CFR Part 11, is required.
  • Mastery of the V-model is imperative.
  • Technical English is a plus.
  • Analytical thinking, rigor, and interpersonal ease are expected.

Responsibilities

  • Participate in system design reviews.
  • Review supplier system FAT protocols and verify their consistency with 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, including the methodology and strategy for the system concerned.
  • Write and execute IQ, OQ, and PQ protocols.
  • Track nonconformities and associated corrective actions.
  • Write qualification reports.
  • Evaluate specific equipment needs for conducting C&Q tests.
  • Train testers on the protocols for the tests to be performed.
  • Plan and coordinate testers and support-service interventions.
  • Write the validation master plan, including the methodology and strategy for the system concerned.
  • Write and execute validation protocols in collaboration with production.
  • Write validation reports.

Desired Qualifications

  • Knowledge of the pharmaceutical sector is strongly appreciated.
  • Technical English is a plus.

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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