Senior Process and Equipment Validation Specialist (IVD)
Capgemini
Capgemini Engineering, a global leader in engineering services, brings together teams of Engineering, Science, and Architecture to help the world’s most innovative companies unlock their potential and contribute to a better future. From autonomous vehicles to life-saving robots, our experts in digital technologies and software think outside the box, delivering unique R&D and engineering services across all industries.
The Digital Continuity & Manufacturing (DC&M) team at Capgemini Engineering specializes in providing strategic solutions for the digitalization of engineering and industrial processes, ensuring digital continuity throughout the entire product lifecycle—from design to maintenance. We focus on optimizing operational efficiency and driving innovation through the integration of advanced technologies such as automation, industrial IoT, and digital twins, helping companies adapt quickly to the market and maintain a competitive edge.
We are seeking a highly motivated Senior Process and Equipment Validation Specialist to lead our process and efforts. This role will play a critical leadership role in ensuring the validation and qualification of manufacturing processes, production equipment, and supporting systems within an IVD-regulated, GMP-compliant environment. This position ensures adherence to IVDR, ISO 13485, FDA, GAMP 5, EU GMP Annex 15, and related global requirements.
Key Responsibilities
- Lead the planning, execution, and lifecycle management of validation activities for IVD manufacturing processes, production equipment, analytical instruments, and utilities in a new manufacturing environment.
- Author, review, and approve Validation Master Plans (VMPs), IQ/OQ/PQ protocols, and summary reports, ensuring scientific justification and regulatory compliance.
- Serve as a subject matter expert (SME) in validation and qualification during internal, notified body, and regulatory inspections (IVDR, FDA, ISO 13485).
- Develop and implement risk-based validation strategies aligned with GAMP 5 and IVD-specific regulatory expectations.
- Partner with Operations, Quality Assurance, and R&D to support the introduction of new technologies, scale-up of manufacturing processes, and design transfers from development to production.
Provide mentorship and technical guidance to staff and cross-functional teams on validation principles and best practices. - Oversee and maintain validation documentation control, ensuring full traceability and audit readiness.
- Support cleanroom qualification, environmental monitoring, and contamination control strategies as part of process validation activities.
- Lead or contribute to continuous improvement initiatives in validation systems, documentation standards, and risk management frameworks.
Qualifications & Experience
Fluent in English (both written and spoken).
Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
Minimum 8 years of experience in process and equipment validation within an in-vitro diagnostics or **medical device manufacturing environment. (Pharmaceutical experience can be considered.)
Working knowledge of FDA 21 CFR 820, IVDR (EU 2017/746), ISO 13485, GMP, and GAMP 5.
Strong analytical, organizational, and communication skills.
Possessing a disability certificate will be positively valued, in line with our inclusion and diversity policy.
We will consider all applications. We offer an extensive range of training opportunities, both in-person and online, including certifications. Even if you don’t meet 100% of the desired qualifications, we’d love to meet you!
Our commitment to inclusion and equal opportunity is reflected in our Equality Plan and Ethical Code, which ensure professional development and fair recruitment in a workplace free from discrimination based on ethnicity, nationality, social background, age, sexual orientation, gender expression, religion, or any other personal, physical, or social circumstance.
What can we offer you?
- An international Digital Continuity & Manufacturing community, where you’ll collaborate with experts from around the world
- Career development plans and training programs tailored to your role
- Access to over 400 internal training activities and platforms such as Coursera, Udemy, Pluralsight, Harvard Manager Mentor, among others
- Language training in English, French, and German through Education First (EF)
Why Capgemini?
Capgemini is a global leader in transforming clients’ businesses by harnessing the full power of technology. We are driven by the purpose of creating an inclusive and sustainable future through technology and the energy of those who develop it. We are a responsible and diverse company, a global leader in IT and Engineering services with over 360,000 professionals in more than 50 countries. With a strong 55-year legacy and deep industry expertise, clients trust Capgemini to meet all their business needs—from strategy and design to operations—powered by the fast-evolving world of cloud, data, AI, connectivity, software, platforms, and digital engineering. In 2022, the Group reported global revenues of €22 billion.
Rewrite your future. Join the team!
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