Validation Engineer

Summary:
Our client is a global biopharmaceutical company based in South Dublin looking for a Validation Engineer to join their team. The successful candidate will be responsible delivering on the commissioning, qualification, and validation (CQV) program. In addition, you will be responsible for planning and executing the sterilization, decontamination, aeration and aseptic processing simulations.

Responsibilities:

• Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process across a varied equipment portfolio.
• Development, review and approval of Validation Plans, QRAES, URS, IV/FTs, SATs, Cycle development and PQs etc. for process equipment in line with GMPs, regulatory requirements, and our client’s standards.
• 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.
• Manage and execute the equipment validation cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.
• Collate and report on relevant validation data and metrics.
• Assist in the development and improvements of the equipment validation and sterilisation lifecycle process while ensuring continued compliance to all applicable regulations and our client’s standards.
• Provide input and guidance into multisite and local procedural requirements.
• Coordinate projects and prioritize workload in line with site priorities.
• 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.
• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
• Participate in regulatory inspections, regulatory filings and RTQs.
• Attend and contribute to staff meetings and attend appropriate training sessions, as required.
• Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
• Perform validation activities using a paperless validation system and identifying opportunities for improvement.

Qualifications & Experience:

• Bachelor of Science/Engineering degree or equivalent.
• 5+ years’ experience in a similar role.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
• In depth experience qualifying filling systems within the sterile manufacturing environment of drug product.
• Previous experience in regulatory inspections.