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Expleo

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

Ingénieur C&Q

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeVitry-sur-Seine, France

About the Job

Requirements

  • A BAC+5 engineering education in general engineering, processes, 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 an advantage.
  • Analytical thinking, rigor, and interpersonal ease are expected.

Responsibilities

  • Participate in system design reviews.
  • Review suppliers’ FAT protocols and check their consistency with the conclusions of the functional analysis.
  • Complete supplier SATs.
  • Receive and commission equipment through FAT and SAT activities.
  • Participate in writing risk analyses and criticality analyses.
  • Write the qualification master plan, setting out the methodology and strategy for the relevant system.
  • Write and execute IQ, OQ, and PQ protocols.
  • Track non-conformities and associated corrective actions.
  • Write qualification reports.
  • Assess specific equipment needs for conducting C&Q tests.
  • Train testers on the protocols for the tests to be executed.
  • Schedule and coordinate testers and support-service interventions.
  • Write the validation master plan, setting out the methodology and strategy for the relevant system.
  • Write and execute validation protocols in collaboration with production.
  • Write validation reports.
  • Make occasional trips, notably to suppliers in France or internationally; geographic mobility within France may be required.

Desired Qualifications

  • Knowledge of the pharmaceutical sector is strongly appreciated.
  • Technical English is an advantage.

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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