Purpose of the role: To ensure equipment is maintained and calibrated to meet engineering and GMP requirements. To support the Operation and Maintenance of equipment as part of the Sterile Operations Team.

Responsibilities include:

Instrumentation, Maintenance and Operations

  • Understand in detail how equipment operates.
  • Support the Sterile Operations Team in the reliable operation, maintenance and calibration of equipment
  • Carry out planned and reactive calibration/ maintenance as required.
  • Assist with the development of  PM schedules for Fill Finish
  • Align Instrument calibrations with relevant Preventative Maintenance routines
  • Develop and comply with relevant SOP’s/WI’s.
  • Ensure spare parts requirements are available and cost effective for equipment
  • Support introduction of maintenance systems within Fill Finish
  • Support Project activities as required to ensure calibration and operational requirements are included. FAT attendance, commissioning and qualification support.
  • Procedure and Calibration assessments for new assets.
  • Problem solving techniques and associated skills are a requirement.

Health, Safety and the Environment

  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.

Quality Compliance

  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.

Ideal candidate for the role:

  • Undergoing or have a relevant third level qualification in Instrumentation or Engineering
  • Minimum 2 years’ experience within a relevant environment (preferably within a Pharma manufacturing environment)
  • Experience in a sterile Manufacturing environment would be an advantage.
  • Experience in a facility start up would be an advantage