Inactive
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Capgemini

Global consulting, technology services, outsourcing

Validation Engineer - Life Sciences

Regulatory & Quality (Life Sciences)Posted on Aug 3
Full-timeDiegem, Machelen, BelgiumNo salary listedIn-person

About the Job

Requirements

  • A Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related technical field is required.
  • Fluency in Dutch and English is required.
  • Two to five years of validation experience in the pharmaceutical or life sciences industry is required.
  • Hands-on experience with equipment qualification (IQ/OQ/PQ), cleaning validation, and/or process validation is required.
  • Knowledge of GMP regulations, FDA/EMA requirements, and industry validation standards is required.
  • Experience with risk assessment methodologies and contamination control strategies is required.
  • Analytical ability to interpret validation data and prepare technical reports is required.
  • Communication and collaboration skills are required to work effectively in cross-functional teams.

Responsibilities

  • Execute validation protocols, including IQ/OQ/PQ for equipment and process validation batches.
  • Develop and review cleaning validation documentation, perform risk assessments, and conduct worst-case analyses.
  • Prepare validation master plans, protocols, and comprehensive validation reports.
  • Collaborate with engineering, production, and quality teams to ensure validation activities align with GMP requirements.
  • Support regulatory inspections and audits by providing validation documentation and expertise.
  • Lead investigations related to deviations and implement Corrective and Preventive Actions (CAPA).
  • Maintain validation lifecycle documentation and perform impact assessments for changes.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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