Senior Manager Validation

Reporting to the Associate Director of Validation, the Senior Manager of Validation provides strategic and operational leadership for validation lifecycle management at the Amgen Dun Laoghaire (ADL) site. The role is accountable for establishing and maintaining the validation status of equipment and systems across drug product manufacturing operations — including formulation, aseptic filling (vials and syringes), lyophilization, capping, and inspection — as well as Warehouse and Laboratory systems. Leading a team of managers and SMEs, this individual ensures compliant, inspection-ready validation programs that enable reliable supply and support successful Technology Transfer (TT) and New Product Introduction (NPI) onto existing and new manufacturing lines. The role partners cross-functionally with Manufacturing, Quality, Engineering, Warehouse Operations, Laboratories, and Regulatory to execute equipment and systems qualifications, Aseptic Process Simulation, and author/review CMC validation sections for global regulatory filings.