Ingénieur Qualification & Validation Des Systèmes Informatisés Csv H/f (cdi)

Polypeptide Group

Strasbourg, France
On-site
Validation of computerized systems
Gmp, 21 cfr part 11, annex 11
Data integrity analysis
PolyPeptide Group is seeking a Qualification and Validation Engineer for their Strasbourg site, responsible for the qualification of production equipment and validation of computerized systems in the pharmaceutical industry. The ideal candidate will have a strong background in validation processes and experience in a regulated environment, along with excellent analytical and interpersonal skills

Job Summary

  • You will ensure the qualification of production equipment and the validation of computerized systems (CSV) for the PolyPeptide site in compliance with established procedures.
  • Key missions include elaborating and maintaining validation documentation such as Validation Master Plan (VMP), Risk Analysis, and SAT/FAT/IQ/OQ/PQ protocols.
  • The role requires a Master's degree (Bac+5) with a specialization in qualification and validation of computerized systems and a minimum of 3 years of experience in the pharmaceutical industry.

Matching Summary

Match Score: 85

PolyPeptide Group is seeking a Qualification and Validation Engineer for their Strasbourg site, responsible for the qualification of production equipment and validation of computerized systems in the pharmaceutical industry. The ideal candidate will have a strong background in validation processes and experience in a regulated environment, along with excellent analytical and interpersonal skills.

Skills & Requirements

Must-have

  • Validation of computerized systems
  • GMP, 21 CFR Part 11, Annex 11
  • Data Integrity analysis
  • URS, FS, DS documentation
  • SAT/FAT/IQ/OQ/PQ protocols
  • Periodic review of systems

Nice-to-have

  • Analytical and synthesis skills
  • Interpersonal skills
  • Rigour, organisation, priorities

Key Requirements

  • Bac+5 in qualification and validation
  • 3 years minimum experience in pharma
  • Proficiency in English (written and oral)

Work Rights

Not specified

Tailored Resume

Cover Letter