Automation Engineer

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 37000 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 peoples 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:

• Bachelors 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.