• A permanent contract with the leader in innovation and high-tech engineering consulting
• A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
• In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
Your role : e stablish and take ownership of the required processes relating to commissioning, qualification and validation, ensuring compliance with all applicable regulatory and internal Quality standards and industry best practices.
• Lead and direct the Commissioning and Qualification team
• Responsible for the compliance of all industrial assets, ensuring that the equipment meets regulatory requirements
• Compliant implementation of new systems through the engineering project phase
• Maintaining compliance of existing systems by delivering appropriate re-qualification and periodic review
• Building compliant processes covering all aspects of the equipment lifecycle (VMP, VPP‘s, specifications, DQ, FAT/SAT, IQ, OQ, PQ & PPQ, requalification and periodic review)
• Design and implement execution strategies, ensure that adequate budget (opex and capex) is planned and spent in support of the C&Q team.
• Masters degree in Process-, Chemical–, Mechanical- or Bio Engineering
• 10+ year experiences in Commissioning, Qualification and Validation within the pharmaceutical or biotechnology sector
• Significant experience of leading C&Q teams in the pharmaceutical industry including biopharmaceutical, sterile fill finish and utility qualification activities, black and clean utilities, Computer Systems Validation,
• Act as a Subject Matter Expert in FAT (SAT) planning and execution
• English fluent, French is a plus.
Ready to join?
We offer in Switzerland an exciting tailored career path for your professional and personal development within an international company. You will be accompanied from the beginning with specific coaching and mentoring programs and intensive training on innovation and management in a fast-moving and results driven environment.