Senior Validation Engineer

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

o Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process across a varied equipment portfolio.

o Liaise with engineering, commissioning and qualification personnel, and external vendors regarding equipment qualification and cycle development best practices ensuring quality by design principles are being followed.

o Manage and execute the equipment validation cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.

o Collate and report on relevant validation data and metrics.

o Assist in the development and improvements of the equipment validation and sterilisation lifecycle process while ensuring continued compliance to all applicable regulations. In addition, provide input and guidance into multisite and local procedural requirements.

o Coordinate projects and prioritize workload in line with site priorities.

o Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams, Validation and C&Q network and ISPE network discussions to influence industry best practices.

o Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.

o Participate in regulatory inspections, regulatory filings and RTQs

o Attend and contribute to staff meetings and attend appropriate training sessions, as required.

o Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.

o Perform validation activities using a paperless validation system and identifying opportunities for improvement



Education & Experience

o Bachelor of Science/Engineering degree or equivalent.

o Knowledge of cGMPs and other worldwide regulatory requirements.

o Experience in a similar role

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.