Proces Validation Engineer

The Process Validation Engineer will work as a member of a project team and will be primarily responsible for the documentation and execution of validation activities in accordance with validation plans and procedures.

Key Job Responsibilities:
• Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
• Generate collection plans for the qualification and acceptance of incoming components including product sub assemblies.
• Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team.
• Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
• Ensure validation documents are up-to-date (primarily project MVPs and key inputs).
• Manage the execution of the product/process validation as per the MVP and project plan.
• Work directly with customer validation representatives to define inputs and requirements to the MVP.
• Ensure all results and data are correct and follow-up on any gaps or discrepancies.
• Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
• Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
• Maintain validation procedures and templates up to date, focusing on continuous improvement.

Job Requirements:
• Degree in Science/Engineering with 3+ years experience in a similar role within the Medical Devices or related Healthcare industry.
• Strong knowledge of ISO and FDA quality requirements.