Job Title: Senior Validation Engineer
We are seeking a skilled and experienced Senior Validation Engineer to join our team in Dublin, Ireland on a 12-month contract. If you have a strong background in validation engineering and a proven track record of delivering successful projects, we would love to hear from you.
The ideal candidate will have at least 5 years' experience in a similar role, with a focus on equipment validation in a GMP regulated environment. You will be responsible for providing validation support to meet objectives, developing and reviewing validation plans, and managing the equipment validation cycle development.
Key Responsibilities:
* Provide validation support to meet objectives 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
Required Qualifications & Experience:
* Bachelor of Science or Engineering degree
* Knowledge of cGMPs and other regulatory requirements
* At least 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