Cqv Lead Biotech/pharma

Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: the world leading engineering and R&D services of Altran - acquired by Capgemini in 2020 - and Capgemini's digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defence, and consumer products.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.

**Descripcion General**:

- 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

**Perfil**:

- 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.