Job Description
I'm delighted to bring a new exciting opportunity for a Validation Engineer to take the step into a Senior role with one of Ireland's leading Biotechnology companies in Dublin on a 12 month contract.
If you have 5+ years' experience in a similar Validation role with specific experience in equipment validation in a GMP regulated environment, then this is an ideal role to take that step into a senior position.
You will be a vital part of the Validation Team responsible for delivering on the commissioning, qualification and validation program.
The responsibilities of the Senior Validation Engineer are:
1. Provide validation support to meet objectives, comprising the full validation lifecycles process across various equipment.
2. Develop, review and approve Validation Plans (URS, IV/FTs, SATs and PQs) for process equipment in line with GMPs & regulatory requirements.
3. Liaise with engineering, commissioning and qualification teams, and vendors regarding equipment qualification ensuring design principles are being followed.
4. Manage and execute the equipment validation cycle development, performance qualifications and requalification program in line with site validation master plans.
5. Support in the development and improvements of the equipment validation and sterilisation lifecycle process.
6. Support cross functional investigation teams, Validation and C&Q network to influence industry best practices.
7. Update and maintain validation SOPs in accordance with site and corporate requirements.
8. Participate in regulatory inspections and regulatory filings
9. Perform validation activities using a paperless validation system and identifying opportunities for improvement
Required Qualifications & Experience
10. Bachelor of Science or Engineering degree.
11. Knowledge of cGMPs and other regulatory requirements.
12. 5+ years' experience in a similar role
13. Experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
14. Experience qualifying filling systems within the sterile manufacturing environment of drug products.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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