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.
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.
- 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