Senior Validation Engineer
We are seeking a highly skilled Senior Validation Engineer to join our team at one of Ireland's leading Biotechnology companies in Dublin on a 12 month contract.
The ideal candidate will have 5+ years' experience in a similar Validation role with specific experience in equipment validation in a GMP regulated environment, and be looking to take the 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.
Responsibilities:
* Provide validation support to meet objectives, comprising the full validation lifecycle 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
Requirements:
* 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.