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Process engineer

Dublin
Arcadis DPS
Process engineer
Posted: 5 July
Offer description

Our client is seeking a highly motivatedProcess Engineer to join theProcess Development Commercial Support team. This team plays a key role in supporting drug product formulation and fill-finish operations, acting as subject matter experts in process and product-related matters. This is a great opportunity for someone with strong experience innew product introductions (NPI),process development, ortechnical transfer in aGMP-regulated environment. Key Responsibilities The successful candidate will contribute to cross-functional teams and support a broad range of technical activities, including but not limited to: Acting as a technical expert in drug product process development, offering solutions to challenges in formulation, vial filling, pre-filled syringe filling, lyophilisation, and vial capping. Supporting product and process investigations by assessing potential impacts and leading root cause analyses. Driving and deliveringcontinuous improvement initiatives to enhance process performance and productivity. Participating in and supportingnew product introductions andtechnical transfers, including protocol execution and recipe development. Performing risk assessments, supporting change controls, and providing product impact assessments for deviations or process changes. Reviewing and approving changes to SOPs, batch records, and product-related documentation. Identifying process gaps and developing strategies to address them. Conducting data trend analysis and troubleshooting performance trends. Required Skills & Experience 6+ years experience in a similar role, preferably in drug product development or manufacturing support (or PhD with 3+ years experience). Bachelor's or Masters degree in Engineering, Science, or a related discipline. Strong experience in product and process investigations (deviation and non-conformance). Demonstrated ability to lead or contribute tocontinuous improvement projects. Solid knowledge ofGMP environments and sterile drug product manufacturing processes. Preferred Qualifications 46 years experience in drug product areas such as formulation, vial or syringe filling, or lyophilisation. Experience inNPI,tech transfer, orMSAT roles. Familiarity with Lean and Six Sigma methodologies (certification a plus). Strong analytical and communication skills with a collaborative, team-oriented approach. Contract Type: 12-month contract (with potential for extension) Onsite Expectation: Minimum 3 days per week onsite (flexible scheduling aligned with team). Shift: 20% ad-hoc shifts to support business needs Skills: Process Engineering Drug Product Manufacturing Support GMP Environments NPI Process Development Tech Transfer Benefits: Parking

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