24th June, 2025
Contract Validation Engineer
West Lothian
12 month contract
The opportunity has arisen for an experienced contract Validation Engineer, to join a well-established Medical Device Company in Livingston. The company has recently experienced a period of growth, and is positioning itself for future growth into key markets. The company requires a talented, dynamic and self-motivated individual to contribute to the existing Engineering team.
Key aspects of the role
- Work alongside the validation team to complete the annual validation schedule; ensuring execution of work and completion of documentation to stringent timeframes, to provide a high degree of assurance that specific processes consistently meet requirements
- Create, execute, and report validation activities, i.e. DQ, IQ, OQ and PQ qualifications, with reference to the User Requirements Specification (URS)
- Execute Clean in Place (CIP) & Sterilisation in Place (SIP) validation activates
- Ensure validation test equipment is current standard and compliant with relevant legislation/guidance.
- Provide validation support for annual standard reviews and process development projects
- Update and create relevant SOP's, QOP's and process documentation, as required.
Applicant requirements - Engineering Degree or equivalent qualification
- Have a “hands on” and proactive approach to validation
- Extensive experience of protocol & Report writing (DQ, IQ, OQ, PQ)
- Minimum 5 years industry experience in one of the following: Medical Device/Pharmaceutical or closely related sectors
- Must be able to apply a risk-based approach to validation data/process validation
- Working knowledge of Quality Management System ISO13485, aseptic processing (ISO13408), sterilisation systems (ISO 11737-1) and other relevant standards
Other desirable attributes - Understanding of high-pressure steam systems and mixing vessels
- Clean in Place (CIP) Validation Strategy and Protocol Execution
Ethelene Oxide Sterilisation experience, would be distinct advantage
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