Manufacturing Operations Specialist

5 days ago


Tullamore, Uíbh Fhailí, Ireland Amgen SA Full time
Job Description

The Manufacturing Operations Specialist at Amgen SA plays a pivotal role in the efficient operation and maintenance of manufacturing equipment. This individual is responsible for monitoring and optimizing manufacturing processes, troubleshooting any issues that arise, and ensuring the quality of final products.

This position reports to the Shift Manager and is accountable for one or more roles related to the manufacture and inspection of sterile parenteral drugs, including but not limited to the operation and setup of manufacturing equipment, processing of parts and components, performing transactions in electronic systems, and cleaning and sanitization of production areas.

This job specification outlines the general responsibilities associated with the role of Manufacturing Operations Specialist on the Amgen Manufacturing Site. The site focuses on continuous improvement of all work processes and practices, and all colleagues are required to be flexible in this regard.

Hiring Requirements:
  • Ability to work a variety of shift patterns, including days, 2, 3, and 4 cycle shifts.
  • Perform all operations with due care and attention, adhering to Good Manufacturing Practices and Amgen requirements.
  • Involved in problem-solving and troubleshooting, including initiation and documentation of investigations.
  • Responsible for the performance of self-inspection Quality & Safety Audits within their functional area.
  • Part of a learning and development program, which includes annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process.
  • Responsible for the cross-training of other colleagues.
  • Responsible for the use, review, revision, and upgrade of operational documentation and peer review of operations.
  • Play a key role in the development of the manufacturing systems and responsible for continuous improvement initiatives.
  • Proactively identify operational improvement opportunities or process-related issues, escalate, and follow up with area Sr. Associate Tech Engineers for effective resolution and implementation.
  • Champions for safe working practices and safety initiatives within their functional area.
  • Carry out any sampling, testing, and inspections that may be required, as well as calibration and maintenance of test equipment.
  • Contribute and assist with Corporate, FDA, HPRA Auditors, and other regulatory bodies during company audits.
  • Carry out any other duty as may be designated by supervisor/management from time to time.


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