At Capgemini Engineering, we strive to unite a global team of engineers and scientists to unleash the potential of innovative companies.
Our services encompass digital and software technology expertise, providing unique R&D and engineering capabilities across all industries.
We seek a detail-oriented Commissioning and Qualification Engineer to join our team. This individual will ensure complex systems and equipment meet specified requirements and regulatory standards in pharmaceuticals, biotechnology, and medical devices.
Job Description:
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
Requirements:
* Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, or related)
* 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
Benefits:
* Supportive atmosphere promoting work-life balance
* Multicultural and inclusive team environment
* Exciting national and international projects
* Hybrid work
* Career growth programs and diverse professionals to support you
* Training and certifications programs
* Health and life insurance
* Referral program with bonus for talent recommendations
* Great office locations