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Process Engineering Support Expert

1 week ago

Sligo, Sligo, Ireland QCS Staffing Full time
The Job:

This is a fantastic opportunity to work in a highly regulated manufacturing environment, supporting the operation of a state-of-the-art pharmaceutical facility. As a Pharmaceutical Equipment Specialist, you will be working as part of an engineering team to ensure compliance with safety, regulatory and organisational requirements.


Responsibilities:
  • Comply with safety, regulatory and organisational requirements.
  • Participate in design and process project conversations to ensure reliability by design.
  • Prepare and own preventative and predictive maintenance procedures for new equipment.
  • Complete and document PMs and pDMs on manufacturing equipment.
  • Manage commissioning spare parts and ensure they are received and catalogued in Maximo.
  • Identify and catalogue critical spare parts in Maximo.
  • Participate in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
  • Review and approve process related commissioning, qualification and validation protocols.
  • Execute protocols to meet project schedule requirements.
  • Liaise with operations, quality and technical operations to maximise equipment and process performance.
  • Maintain records and documentation on relevant Engineering Procedures.
  • Liaise with Internal/External Engineering Personnel and contract maintenance providers.
  • Complete instrument calibration as per schedule.
  • Manage the outsourced condition monitoring contracts, implement recommendations and track to closure.
  • Implement equipment/process upgrades in an environment of continuous improvement.
  • Support the Production Team to ensure manufacturing equipment meets output and yield requirements.
  • Adhere to all relevant policies relating to Quality & Safety.
  • Ensure successful external inspections and Division/Corporate audits.
  • Supervise external contractors.