Cqv Lead Biotech/pharma

vor 2 Wochen

Lausanne, Schweiz Capgemini Engineering Vollzeit

Critères de l'offre

Description du poste
- 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

Description du profil
- 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?

Capgemini Engineering will be on the forefront in creating an optimal work-life balance, more autonomy in where and how our people work and to embrace the learnings we have experienced from wider-scale remote working. For you, this may mean less time in the office than usual with some time working from home, whereas other roles and engagements will continue to be more location-dependent or office-based. Together with your manager, you will agree an approach which works for you, your team and our business.

In order to deploy this novel way of working, we have introduced our New Normal policy which includes:
30% to 70% remote work in agreement with your line manager and client needs
Trust-based managerial culture
Team rituals and get togethers
Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.

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