At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Project Overview
We're looking for a detail-oriented Commissioning and Qualification Engineer to join our team at Capgemini Engineering. You'll ensure complex systems and equipment meet all specified requirements and regulatory standards in pharmaceuticals, biotechnology, and medical devices.
Technical Profile Requirements
* Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, or related)
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* Proficiency in cGMP, FDA, and EMA regulations
* Strong understanding of C&Q processes (IQ/OQ/PQ)
* Experience with GAMP 5 and computerized system validation
* Familiarity with risk management methodologies (FMEA, HACCP)
* 5+ years of C&Q experience in regulated industries
• Excellent communication and problem-solving skills
Soft Skills & Collaboration Profile
* Ability to work independently with a strong sense of responsibility
* Comfortable integrating into multidisciplinary and agile teams
* Strong communication skills and ability to adapt to international environments
Key Responsabilities
Develop and execute C&Q protocols for equipment, utilities, and facilities
Perform risk assessments and create validation master plans (cGMP)
Collaborate with cross-functional teams on C&Q activities
Analyze test results and prepare comprehensive reports
Troubleshoot and resolve issues during C&Q process
Stay current with industry regulations and best practices
Mentor junior team members and drive continuous improvement
Nice to Have: Experience with Kneat and Veeva validation management systems
Background in quality management systems implementation
Work Model
* Hybrid model: 2 days on-site per week
What you will love about working here
* Enjoy a supportive atmosphere promoting work-life balance.
* Join a multicultural and inclusive team environment.
* Engage in exciting national and international projects.
* Hybrid work.
* Your career growth is central to our mission. Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities.
* Training and certifications programs.
* Health and life insurance.
* Referral program with bonus for talent recommendations.
* Great office locations.
About Capgemini
Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you'd like, where you'll be supported and inspired by a collaborative community of colleagues around the world, and where you'll be able to reimagine what's possible.
Join us and help the world's leading organizations unlock the value of technology and build a more sustainable, more inclusive world.