Commissioning, Qualification & Validation (CQV) Engineer | Life Science

Capgemini Engineering; Diegem; On-site; EUR 45,000 - 65,000; Full time

Job summary

Capgemini Engineering is seeking a Commissioning, Qualification and Validation Engineer for the pharmaceutical industry. You will join expert teams ensuring compliance and quality of pharmaceutical facilities and equipment.

Responsibilities include developing and executing qualification/validation protocols, performing CQV activities, IQ/OQ/PQ testing, and collaborating with multidisciplinary teams. Requirements include an engineering degree in pharmaceutical engineering or related field,

Qualifications

• Knowledge of GMP and pharmaceutical regulations.
• Internship in pharma or regulated environment.
• English fluent with good Dutch skills in writing and speaking.

Responsibilities

• Develop and execute qualification/validation protocols for pharma equipment and systems.
• Perform CQV activities per GMP and pharma regulations.
• Execute IQ/OQ/PQ testing to verify installation, operation and performance.
• Collaborate with multidisciplinary teams to ensure facility compliance.
• Document test results and write detailed technical reports.
• Identify deviations and participate in corrective actions.

Skills

English fluency

Dutch proficiency

Education

Engineering degree in pharmaceutical/related field

Job description

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 mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe same.

Your Role

As a Commissioning, Qualification and Validation Engineer in the pharmaceutical industry, you will join our expert teams dedicated to ensuring compliance and quality of pharmaceutical facilities and equipment.

• Participating in the development and execution of qualification and validation protocols for pharmaceutical equipment and systems
• Performing commissioning, qualification and validation (CQV) activities in accordance with Good Manufacturing Practices (GMP) and pharmaceutical regulations
• Executing IQ/OQ/PQ testing to verify that systems and equipment are installed correctly, operate as intended, and perform consistently according to specifications
• Collaborating with multidisciplinary teams to ensure facility compliance with regulatory requirements and client specifications
• Documenting test results and writing detailed technical reports
• Identifying deviations and participating in the implementation of corrective actions.

Your Profile

• You hold an engineering degree or equivalent in pharmaceutical engineering, biochemistry, process engineering or related field
• You have completed at least one internship in the pharmaceutical industry or in a similar regulated environment
• You have knowledge of Good Manufacturing Practices (GMP), pharmaceutical regulations, and IQ/OQ/PQ methodologies
• You are fluent in English and have a good level of Dutch, both written and spoken

What You'll Love About Working Here

• Own your Growth: Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more. Our engineering academy offers more than 60,000 hours of training to support your professional development.
• Connect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.
• Lead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies to help our clients develop the smart products and services of tomorrow.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.