Our Mid-West based multinational client currently has a requirement for an experienced Facilities Validation Engineer to join their expanding engineering team. The successful candidate will have 4-5 years excellent experience gained in the medical devices or pharmaceutical manufacturing sectors.
This is a 9-12 month contract position with salary range of 50,000-60,000.
Job duties will include:
*Supporting the activities of Operations / Engineering / Information Management in assuring compliance with the regulations
* Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
* Implement policies and procedures.
* Work with the various departments / groups in development and execution of validation activities associated with new equipment / product or System upgrades.
* Run / Manage complaint investigation and resolution of same.
* Design and develop validation documentation to support business continuity, new process introductions, etc.
ReviewCandidate Requirements:
- 3rd level Degree in an engineering field is essential.
- 4-5 years experience at a similar position within a multinational organisation in the FDA medical devices or pharma sectors is essential.
- In-depth knowledge of FDA/ISO regulations.
- Proven track record in development/execution of validation programs.
Experience in the following areas is of specific interest:
Commissioning and Qualification of Critical Utilities including but not limited to:
· DI water
· Compressed Air
· Nitrogen
· HVAC
- Commissioning and Qualification of equipment and qualification of laboratory equipment.
- Commissioning and Qualification documentation generation, review and approval, where appropriate, including - Validation Project Plans, fMEAs/ Risk Assessments, User Requirement Specification, Functional Design Specification, Factory Acceptance Testing, Site Acceptance Testing, Commissioning Test Plans,
IQ, OQ and PQ Protocols and reports/investigations.
For further information please contact Thomas Hogan at CPL Limerick on 061 221701 or email a Cv in confidence to thomas.hogan@cpl.ie