Equipment Qualification Engineer | Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Capgemini Engineering is seeking a Qualification/Validation professional to support the Equipment Requalification program at the Geel site in Belgium. You will work on-site with Engineering, Quality, Manufacturing, and Validation teams to deliver GMP documentation and ensure regulatory compliance.

You will prepare and review IQ/OQ/PQ and CQV activities for utilities, facilities, and process equipment, contributing to a compliant quality transformation initiative.

Qualifications

• Minimum 3 years of experience in equipment qualification or a related role within a pharmaceutical or biopharmaceutical manufacturing environment
• Hands-on experience with IQ / OQ / PQ protocols, CQV methodologies, and GMP / GxP documentation standards
• Experience with utilities, facilities, and process equipment in a regulated manufacturing setting
• Strong understanding of deviation management and CAPA processes, with the ability to contribute to remediation plans
• Fluency in English and Dutch for effective communication with local site teams in Geel

Responsabilités

• Supporting equipment qualification and requalification activities within a GMP-regulated pharmaceutical manufacturing environment, ensuring all activities are executed to the highest quality and compliance standards
• Preparing, executing, and reviewing IQ / OQ / PQ documentation in line with GMP / GxP requirements, contributing to the overall success of the Equipment Requalification workstream
• Contributing to Commissioning, Qualification, and Validation (CQV) activities, including the assessment and requalification of utilities, facilities, and process equipment
• Managing and contributing to deviation identification, CAPA follow-up, and remediation plans related to equipment qualification gaps, ensuring timely and compliant resolution
• Supporting inspection readiness activities when required, ensuring documentation and processes are audit-ready at all times

Connaissances

IQ / OQ / PQ

CQV

GxP documentation

Deviation management

CAPA processes

English

Dutch

Autonomous on-site work

Cross-functional collaboration

Description du poste

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

In this role, you will play a key role in supporting our client's Equipment Requalification program at their Geel site in Belgium, working as part of a broader global Quality Transformation initiative. You will work autonomously on-site, collaborating closely with Engineering, Quality, Manufacturing, and Validation teams to deliver high-quality GMP documentation and ensure full compliance with regulatory standards.

• Supporting equipment qualification and requalification activities within a GMP-regulated pharmaceutical manufacturing environment, ensuring all activities are executed to the highest quality and compliance standards
• Preparing, executing, and reviewing IQ / OQ / PQ documentation in line with GMP / GxP requirements, contributing to the overall success of the Equipment Requalification workstream
• Contributing to Commissioning, Qualification, and Validation (CQV) activities, including the assessment and requalification of utilities, facilities, and process equipment
• Managing and contributing to deviation identification, CAPA follow-up, and remediation plans related to equipment qualification gaps, ensuring timely and compliant resolution
• Supporting inspection readiness activities when required, ensuring documentation and processes are audit-ready at all times

Your Profile

We are looking for an experienced Qualification / Validation professional who is confident working autonomously in a fast-paced, regulated pharmaceutical environment. You will bring strong technical knowledge, a rigorous approach to documentation, and the ability to collaborate effectively with cross-functional site teams.

• Minimum 3 years of experience in equipment qualification, validation, or a related role within a pharmaceutical or biopharmaceutical manufacturing environment
• Hands-on experience with IQ / OQ / PQ protocols, CQV methodologies, and GMP / GxP documentation standards, with the ability to both prepare and critically review qualification documentation
• Demonstrated experience working with utilities, facilities, and process equipment in a regulated manufacturing setting, including involvement in commissioning and qualification activities
• Strong understanding of deviation management and CAPA processes, with the ability to contribute to remediation plans and support cross-functional teams in resolving qualification gaps
• Fluency in English and Dutch for effective communication with local site teams in Geel

What You Will Love About Working Here

• Impact Together Week - During this week, we volunteer for activities supporting a sustainable and inclusive future. Over 7,000 volunteers have contributed skills and time to help those in need.
• Mentoring programs - Capgemini empowers women at all career stages with programs spanning STEM education to career reentry. We value mentorship for fostering professional growth and empowerment within our engineering community.
• Free access to learning platforms - 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.

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.