Pharma/biotech Cqv

**Short Description**:
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.

**Qualifications**:
**Education level**:

- Msc, PhD in Engineering is required for this position.
- Minimum 5 years of experience in Quality Engineering or Validation Engineering
- Applied knowledge of FDA and international Pharmaceutical and or medical device regulations is preferred
- Applied technical understanding of manufacturing equipment; processes specific to pharmaceutical and or medical device manufacturing preferred
- Demonstrated problem solving and troubleshooting skills
- Demonstrated effective verbal and written communication skills
- Demonstrated results orientation, ability to multi-task, quick learner, team player and demonstrated ability to respond to urgent needs and deliver expected results in a deadline driven environment

**Responsibilities**:
To strengthen our team in Life Science, we are looking for a talented Qualification and Validation Engineer.

The Qualification and Validation Engineer will support and conduct validation studies, technology transfer activities, process characterization studies and gauge R&R studies within the Manufacturing Process. This position will also provide guidance on the equipment/process validation requirements and design control activities for new product development projects.
- Support/conduct FAT/SAT and then IQ/OQ/PQ validation studies of equipment and processes, utilities and software validations
- Advise project teams, develop/review and approve validation protocols and final reports
- Manage Change Control on material specifications and documentation, develop and validate test method validation (Gage R&R)
- Support of continuous improvement on process, and on Qualification and Validations project
- Support on Non Conformity, CAPA, Internal audits and failure investigations
- Participate in project planning, scheduling, and tracking
- Develop and implement procedures to comply with corporate and industry standards
- Provide validation training to Operations employees