Validation Engineer

NeuchatelTemporaire2018-11-22Bachelor / Collège / Diplôme
Nous recrutons Un/e Ingénieur/e validation pour une mission temporaire longue durée.

Validation Engineer

Your Responsibilities

  • Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
  • Author qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports
  • Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
  • Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
  • Participate to risk assessments and risk management teams
  • Review change controls / DISIDI documents to evaluate impact on qualified systems and validated processes
  • Develop and justify the validation approach based on risk and a scientific rational
  • Co-ordinate qualification and validation execution activities, including external vendors and internal departments

Your Profile

  • BS in Engineering or Technical discipline.
  • Knowledge of cGxP requirements
  • Experience with qualification and validation at a solid dosage plant is an advantage
  • Team player: ability to interact effectively with team and customers
  • Good communication skills
  • Ability to read & write in English, French advantageous

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -112018-294262