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:
* Provide validation support to meet objectives, comprising the full validation lifecycles process across various equipment.
* Develop, review and approve Validation Plans (URS, IV/FTs, SATs and PQs) for process equipment in line with GMPs & regulatory requirements.
* Liaise with engineering, commissioning and qualification teams, and vendors regarding equipment qualification ensuring design principles are being followed.
* Manage and execute the equipment validation cycle development, performance qualifications and requalification program in line with site validation master plans.
* Support in the development and improvements of the equipment validation and sterilisation lifecycle process.
* Support cross functional investigation teams, Validation and C&Q network to influence industry best practices.
* Update and maintain validation SOPs in accordance with site and corporate requirements.
* Participate in regulatory inspections and regulatory filings.
* Perform validation activities using a paperless validation system and identifying opportunities for improvement.
Required Qualifications & Experience
* Bachelor of Science or Engineering degree.
* Knowledge of cGMPs and other regulatory requirements.
* 5+ years' experience in a similar role.
* Experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
* Experience qualifying filling systems within the sterile manufacturing environment of drug products.
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