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Onsite Validation Engineer – Life Sciences
Posted 6 hours ago
About the role
- Validation Engineer ensuring compliance in pharmaceutical manufacturing processes at Capgemini Engineering. Collaborating with cross-functional teams to optimize validation processes and documentation.
Responsibilities
- 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.
Requirements
- Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or related technical field
- 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.
Benefits
- Continuous feedback: We take human-centric approach to foster growth and performance.
- 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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