Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
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, Inspection 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.
- 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 2+ years’ experience in operations/manufacturing environment.
- Background in automation design, installation, programming. Experience with validation, and lifecycle maintenance is an advantage.
- Experience in Biopharmaceutical Formulation/Fill/Finish or Inspection or Packaging facilities is an advantage
- Experience in programming and troubleshooting of PLC, HMI, SCADA, Serialisation, and Vision 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.