ConvaTec Group is seeking a Validation Engineer to be responsible for the commissioning and qualification of processes and manufacturing equipment within their medical products division. The role requires a strong understanding of validation processes in regulated environments, particularly ISO 13485 and FDA requirements.
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Job Summary
The Validation Engineer is responsible for commissioning and qualification of processes and manufacturing equipment, participating in various projects from capacity upgrades to new facilities.
Key responsibilities include contributing to URS, providing input for design documents, documenting deviations, and executing validation protocols (IQ, OQ, PQ).
The role requires a degree in a relevant discipline, experience with GMP/cGAMP, and the ability to work effectively with cross-functional site teams.
Matching Summary
Match Score: 85
ConvaTec Group is seeking a Validation Engineer to be responsible for the commissioning and qualification of processes and manufacturing equipment within their medical products division. The role requires a strong understanding of validation processes in regulated environments, particularly ISO 13485 and FDA requirements.
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Skills & Requirements
Must-have
Commissioning and qualification of processes
Manufacturing equipment validation
cGAMP and GMP understanding
User Requirement Specification (URS)
IQ, OQ, PQ execution
Cross-functional team collaboration
Nice-to-have
ISO 13485 and FDA requirements
CE marking experience
Calibration, measurement techniques, and statistics