Posted: 18 June
The role
Career Category EngineeringWhat you will doAmgen Dun Laoghaire (ADL) is looking for an Equipment Process Engineer to join our Drug Product Engineering team to support commercial aseptic drug product filling on site at our facility.Key ResponsibilitiesSupport a safe working environment by complying with all pertinent environmental health & safety practice, rules and regulations.Own equipment/systems in a GMP regulated manufacturing setting that support Drug Product manufacturing processes.Monitor day‑to‑day performance, including trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.Support system improvements, development of detailed specifications, engineering documents and standard operating procedures.Support technical root cause analysis, incident investigations and after‑action reviews when troubleshooting issues related to manufacturing equipment/systems.Solve complex problems, manage projects, oversee equipment lifecycle management and operational excellence initiatives related to their systems/equipment.Develop and manage change control requests per established SOPs and processes.Support new product introductions or new technology introductions by performing engineering assessments, implementing system changes and supporting engineering runs.Communicate with key stakeholders in a responsive manner to keep them informed on all engineering activities.Work in a collaborative manner within cross‑functional work centre teams and contribute to investigations, Non‑Conformance and CAPA closure.Develop a structured maintenance schedule that aligns with the manufacturing schedule to minimise downtime, including routine PMs and long‑term planning for vendor support on site.Develop and maintain spare parts lists for their system and ensure appropriate levels of spares are maintained.Basic QualificationsBachelor's degree in Engineering (Mechanical, Manufacturing, Mechatronics, Electrical or Chemical).Manufacturing experience in a regulated environment.Experience with statistical analysis tools and continuous improvement methodologies.Problem‑solving and applied engineering skills relating to mechanical, electro‑mechanical and associated automation systems.Preferred QualificationsManufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities.Technical writing, communication and presentation skills.Experience in change control, non‑conformance, corrective and preventative actions, and validation practices.Experience developing strategies for new product introduction and new technology deployment.Ability to translate strategic opportunities and emerging technology solutions into actionable plans.Experience developing and presenting project plans to management.Day‑to‑day vendor management experience.Independent, self‑motivated, organised, able to multi‑task in project environments and skilled in communication and collaboration.Team player, prepared to work in a team‑based culture that relies on collaboration for effective decision‑making.Travel at various times may be required.BenefitsCompetitive salary structure.Generous Total Rewards Plan for staff and eligible dependents.Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance.Discretionary annual bonus program.Exceptional learning, development and career advancement opportunities.Salary Range: 55,960.60 EUR - 75,711.40 EURAmgen is an equal opportunities employer.
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