Ci Specialist - Validation

Sanofi

Le Trait, France
Hybrid
Validation strategies for critical equipment
Iq/oq/pq protocols and reports
Cgmp and bpf compliance
Sanofi is seeking a CI Specialist - Validation for their Le Trait facility, focusing on ensuring compliance and performance of critical equipment and processes in a sterile injectable environment. The ideal candidate should have experience in equipment validation within the pharmaceutical or biotechnology industries, along with a strong knowledge of regulatory standards

Job Summary

  • As a CI Specialist within our Quality team, you will contribute to ensuring the compliance and performance of critical equipment and processes at the Le Trait site, by piloting validation strategies in a sterile and injectable environment.
  • Define and implement validation strategies for critical site equipment: autoclaves, gamma irradiation, electron beams (e-beam), isolators, cleaning processes, and aseptic filling.
  • Benefit from attractive advantages: comprehensive health coverage, flexible working arrangements, and well-being programs.

Matching Summary

Match Score: 85

Sanofi is seeking a CI Specialist - Validation for their Le Trait facility, focusing on ensuring compliance and performance of critical equipment and processes in a sterile injectable environment. The ideal candidate should have experience in equipment validation within the pharmaceutical or biotechnology industries, along with a strong knowledge of regulatory standards.

Skills & Requirements

Must-have

  • Validation strategies for critical equipment
  • IQ/OQ/PQ protocols and reports
  • cGMP and BPF compliance
  • Sterile and injectable process validation
  • Regulatory inspections and audits

Nice-to-have

  • Positive and motivating work environment
  • Collaboration with project, production teams
  • Continuous learning and development

Key Requirements

  • Experience in equipment/process validation
  • Knowledge of cGMP, BPF, ICH, pharmacopoeia
  • Experience with sterile/injectable processes
  • Bac+5 degree in science or equivalent experience
  • English B2 level

Work Rights

Not specified

Tailored Resume

Cover Letter