Amgen in Dun Laoghaire is seeking an Automation Engineer to support the operation of complex automation systems in a GMP-regulated environment. The role involves maintaining validated systems, leading troubleshooting efforts, and implementing improvements using the latest technology. The ideal candidate will have a Bachelor's in Electrical Engineering or a related field and 4+ years of relevant experience. Knowledge of PLC, HMI, SCADA systems, and strong communication skills are essential. Join Amgen to help improve health outcomes through innovative drug manufacturing. #J-18808-Ljbffr
The Automation Engineer will be a member of the team supporting the day‑to‑day operation of complex automation systems at Amgen Dun Laoghaire (ADL) which is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. Amgen is developing the capability to produce all its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally. Key Responsibilities Safety: Support a safe working environment by complying with all pertinent environmental health/safety practice and regulations. Maintain: Be the System Owner for automation systems in a GMP-regulated manufacturing setting ensuring systems are maintained in the validated state. Investigate: Lead and support incident investigations and troubleshooting efforts related to manufacturing automation systems. Improve: Implement improvements related to corrective or preventative actions; including software changes, and updates to design documentation and standard operating procedures. Innovate: Analyse the design of current systems, to recommend continuous improvements in line with the latest technology and regulatory standards. Innovate: Support new product or technology introductions by performing engineering assessments, implementing automation system changes, and supporting engineering runs. Preferred Qualifications and Experience Bachelor’s in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering with 4+ years’ experience in operations/manufacturing environment. Background in automation design, installation, programming. Experience with validation, and lifecycle maintenance is an advanvtage. Experience in Biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities is an advantage Experience in programming and troubleshooting of PLC, HMI, SCADA, and Batch Systems. The systems at ADL include Siemens S7-300/400/1500 and Rockwell CompactLogix/ControlLogix PLCs; Siemens and Rockwell HMIs; iFix, InTouch, Zenon, PCS7, and Rockwell FTView SCADAs; and Fieldbus systems such as ControlNet (CNET), DeviceNet, Profibus, ProfiNet etc. Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11. Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls Independent, self‑motivated, organised, and able to multi‑task in a manufacturing environment Team player, prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making Solid technical writing, and communication/presentation skills Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals Travel at various times may be required to support training and vendor visits. #J-18808-Ljbffr
Overview Amgen is the world’s leading biopharmaceutical company with a versatile portfolio of products. Our science-based approach has led to the discovery of novel therapies in cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. Our patient-centred culture fuels our commitment to delight their experience with innovative medicine delivery systems. At Amgen, new ideas are not just welcomed but celebrated. You will be joining a team of over 20,000 inspirational colleagues eager to have a positive impact with one mission: to serve every patient every time. What You Will Do As a member of the ADL Technology Team, this role will support and enhance computerized systems within a highly GMP-regulated environment by translating operational and quality requirements into compliant system specifications. Ensure all system changes adhere to established quality procedures and work closely with Quality Assurance, Manufacturing, Supply Chain, and external vendors to meet audit and regulatory expectations. Demonstrate a strong understanding of GMP principles, with a consistent focus on data integrity, high-quality documentation, and regulatory compliance. ADL Technology Operations Support: Specialist IS Business Systems Analyst, Operations Technology . This position will report to the Associate Director, Technology in Ireland. Responsibilities Effectively manage relationships with business partners and delivery of L2 support services to customers. Liaison between business stakeholders and product owners. Troubleshoot and resolve system issues in the manufacturing and supply chain area within SAP environment, including master data maintenance. Support system configuration, testing, and deployment activities across the application lifecycle. Own responsibility for system availability, security, validation, compliance, and lifecycle management (e.g. CMMS, QBMS). Coordinate with internal partners and external vendors on system upgrades, ongoing support, and enhancements. Collaborate closely with Quality Assurance, Manufacturing, Supply Chain, and Automation partners, maintaining documentation, SOPs, and system configuration records. Ensure adherence to internal policies, data governance standards, and regulatory requirements. Utilize AI, visualizations and digital solutions to improve efficiency and productivity. Communicate with transparency and influence. Travel: Domestic and international travel up to 20% may be required. Basic Qualifications Bachelor's degree and at least 6 years of Information System and/or manufacturing technology experience Master’s degree and at least 4 years of Information System and/or manufacturing technology experience. Preferred Qualifications Bachelor’s degree in computer science, Engineering or Information Systems Understanding of GMP-regulated environments Technical depth across Information and Operations Technology (IT/OT) and demonstrated ability to lead technology change. Strong hands-on experience with SAP in manufacturing and SCM contexts. Experience with SAP master data and pricing, Manufacturing and quality systems (CMMS, QBMS), ServiceNow request and change workflows. Strong stakeholder communication across technical and business teams, including experience engaging with senior stakeholders. #J-18808-Ljbffr
A global biopharmaceutical company in Ireland is seeking a Specialist IS Business Systems Analyst to enhance computerized systems within a GMP-regulated environment. The successful candidate will manage relationships with business partners and support system configurations while ensuring compliance with quality procedures. A Bachelor's degree and extensive experience in Information Systems, especially with SAP, are essential. This position may require domestic and international travel up to 20%. #J-18808-Ljbffr
