Sr. Technology Project Engineer

Job Description
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, kidney disease, rheumatoid arthritis, 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.

Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. 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 of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally.

As a member of the Technology Projects Team, the role will support complex and challenging system Technology initiatives and project delivery.

1. Responsible for supporting all tasks related to the technology system project lifecycle, from solution design to GMP qualification.
2. Project management and execution of assigned projects including project prioritisation, resource management, status reporting and external communication.
3. Working with various stakeholders to scope projects and ensure requirements are satisfied.
4. Critically analysing system design, developing, and recommending continuous improvements in line with the latest technology and regulatory standards.
5. Work in a collaborative manner within cross functional teams.
6. Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures.
7. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
8. Solving complex problems, lifecycle management and operational excellence.
9. Develop and manage change control requests per established SOPs and processes.
10. Develop detailed specifications, engineering documents, system impact assessments, test protocols and standard operating procedures.
11. Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.
12. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
13. Travel at various times may be required to support execution of projects.

1. Bachelor's in electrical engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years' experience in operations/manufacturing environment.
2. Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities.
3. Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment.
4. Experience programming and troubleshooting PLC (e.g. Allen Bradley, Siemens, B&R), SCADA (e.g. IFix, InTouch, Zenon), PCS (e.g. Rockwell Automation Platforms) and Batch Systems (e.g. Factory Talk Batch).
5. Industrial Networking experience with ControlNet (CNET), DeviceNet, Profibus etc.
6. Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk AssetCentre, ThinManager and OSIsoft PI Data Historian.
7. Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.
8. Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls.
9. Solid leadership, technical writing, and communication/presentation skills.
10. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
11. Experience in developing technology strategies for new product introduction and new technology deployment.
12. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
13. Ability to influence the development of business area strategy and Technology strategy where appropriate.
14. Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements.
15. Independent, self-motivated, organised and able to multi-task in project environments.
16. Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
17. Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals.