Validation Engineer | Life Sciences

Capgemini Engineering

Diegem

Sur place

EUR 45 000 - 65 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Continuous feedback and performance discussions
FlexAbroad opportunity
Access to a digital campus and training resources

Résumé du poste

Capgemini Engineering in Diegem, Belgium, is seeking a Validation Engineer to ensure compliance in pharmaceutical manufacturing. This role includes executing validation protocols, preparing documentation, and supporting regulatory inspections. You will work closely with cross-functional teams to optimize validation processes while maintaining high quality and regulatory standards.

The ideal candidate holds a Bachelor’s or Master’s degree and has 2-5 years of experience in validation. Join us to be part of groundbreaking projects and continuous professional growth!

Qualifications

  • 2-5 years of experience in validation within the pharmaceutical or life sciences industry.
  • Strong knowledge of GMP regulations, FDA/EMA requirements, and industry validation standards.
  • Experience with risk assessment methodologies and contamination control strategies.

Responsabilités

  • Executing validation protocols including IQ/OQ/PQ for equipment and process validation batches.
  • Developing and reviewing cleaning validation documentation.
  • Collaborating with engineering, production, and quality teams.

Connaissances

Fluency in Dutch
Fluency in English
Hands-on experience with IQ/OQ/PQ
Strong analytical skills
Excellent communication skills

Formation

Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Chemistry

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 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.

Your Role

As a Validation Engineer, you will play a crucial role in ensuring pharmaceutical manufacturing processes, equipment, and cleaning procedures meet regulatory requirements and quality standards. Working with cross‑functional teams, you’ll help our clients maintain compliance while optimizing their validation processes.

In this role you will play a key role in:
  • Executing validation protocols including IQ/OQ/PQ for equipment and process validation batches
  • Developing and reviewing cleaning validation documentation, performing risk assessments and worst‑case analyses
  • Preparing validation master plans, protocols, and comprehensive validation reports
  • Collaborating with engineering, production, and quality teams to ensure validation activities align with GMP requirements
  • Supporting regulatory inspections and audits by providing validation documentation and expertise
  • Leading investigations related to deviations and implementing CAPA (Corrective and Preventive Actions)
  • Maintaining validation lifecycle documentation and performing impact assessments for changes
Your Profile
  • Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or related technical field
  • Fluency in Dutch and English
  • 2‑5 years of experience in validation within the pharmaceutical or life sciences industry
  • Hands‑on experience with equipment qualification (IQ/OQ/PQ), cleaning validation, and/or process validation
  • Strong knowledge of GMP regulations, FDA/EMA requirements, and industry validation standards
  • Experience with risk assessment methodologies and contamination control strategies
  • Excellent analytical skills with ability to interpret validation data and prepare technical reports
  • Strong communication and collaboration skills to work effectively in cross‑functional teams
What You’ll Love About Working Here
  • Continuous feedback: We take a human‑centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check‑ins with managers, and ongoing performance discussions.
  • FlexAbroad: Employees in 20+ countries can work abroad for up to 45 days in a 12‑month period.
  • Digital campuses and academy: Our engineering academy offers more than 60,000 hours of training, as also our digital campus on GenAI, data or sustainability, support digital learning in the flow of work from awareness to expert certifications.
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