Validation Senior Engineering Specialist
MSD · Carlow, Leinster, IE
Job Description A new and exciting opportunity has come for a Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations.
Job description
Job Description A new and exciting opportunity has come for a Validation Senior Engineering Specialist(s) on our Carlow Site with Technical Operations. The successful candidate will be responsible for: Leadership of validation activities within the Recovery and Cleaning qualification team and across other validation teams. Maintaining compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance. Supporting regulatory audits and submissions as required. What you will do: Bring energy, knowledge, innovation, and leadership to carry out the following: Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies. Responsible for setting and delivery of validation strategies. Lead and supports complex & critical investigations associated wit...