Amgen - Ireland, Hybrid work

Senior Engineer, Process Development sought for Amgen’s Dun Laoghaire site to drive syringe filling line expansion. This role focuses on filling characterisation, single-use technology qualification, and cGMP manufacturing support for large and small molecule drug products. Ideal candidates bring...

Senior Associate - QC Technical Services sought by Amgen in Dun Laoghaire, Ireland. This role manages laboratory system qualification, calibration, and maintenance within a cGMP environment. Key responsibilities include overseeing the CMMS Maximo, authoring validation lifecycle documents, and ens...

Validation Manager role in Dun Laoghaire, Ireland, leading aseptic process validation for drug product manufacturing. You will manage a team overseeing sterilization, HVAC, isolators, and autoclaves, ensuring GMP compliance. Requires 5+ years in Validation or Engineering with a Master’s degree. D...

Seeking a strategic **Project Portfolio & Governance Manager** in **Dun Laoghaire, Ireland**. You will lead the PMO and Site Master Plan for a cGMP manufacturing site, requiring 6+ years in engineering/capital projects and 5+ years in leadership. Drive portfolio analysis, governance, and IBP proc...

Senior Manager, External Quality sought for a hybrid role in Dun Laoghaire, Ireland. Leverage 10+ years of biotech/pharma experience to provide quality oversight at CMOs, manage deviations, and drive batch disposition. Requires expertise in aseptic manufacturing, QP eligibility, and strong stakeh...

Senior Equipment Engineer – Packaging System Owner sought by Amgen Dun Laoghaire to lead automated packaging and inspection systems in a GMP-regulated environment. This role requires a Bachelor’s in Engineering, 5+ years of pharma/medical device experience, and expertise in continuous improvement...

Regulatory Affairs Manager sought by Amgen in Dun Laoghaire, Ireland. You will lead CMC regulatory strategy, manage global dossiers for MAAs and CTAs, and ensure compliance. Requires a Doctorate or Master’s with 3+ years of Regulatory CMC experience. Join a global biotech leader offering a divers...

Associate Director, External Supply Manufacturing Support, leading a new centralized organization at Amgen’s ACDM in Dun Laoghaire, Ireland. Leverage 8+ years of pharmaceutical manufacturing and 4+ years management experience to drive Drug Substance and Drug Product operations. This role demands ...

Seeking a Manufacturing Process Owner for External Supply in Dun Laoghaire, Ireland. This key role drives execution excellence at CDMOs, focusing on Aseptic DP (Formulation, Filling, Lyophilisation) or Capping/Visual Inspection/Packaging. Requires 5+ years cGxP experience, a Bachelor's in Science...

Lead the Validation function at Amgen's advanced sterile fill-finish site in Dun Laoghaire. This strategic director role requires extensive sterile manufacturing experience, expertise in aseptic process simulation, and capital project leadership. Drive operational excellence, ensure compliance, a...

Lead validation strategy and lifecycle management for drug product manufacturing at Amgen's Dun Laoghaire site. This senior role requires 8+ years' management experience in a GMP pharmaceutical/biotech environment, with expertise in sterile processing and equipment validation. You will oversee a ...