This is an 11 month contract
This is a contingent position which will support the start-up activities and programs required for the operational readiness plan for manufacturing at the new site in the Company. The Engineer will work closely with a team of design and build engineers to transition from project to sustain for all manufacturing assets and processes.
• Perform supporting activities for operational readiness, equipment qualification and site projects.
• Co-ordinate and support site engineering and maintenance reliability initiatives and programmes.
• Author compliance documents e.g. SOPs, WIs, Change Controls.
• Identify, negotiate and onboard specialist service providers to support the maintenance of Biotech manufacturing equipment and instruments.
• Set up a variety of maintenance tasks including but not limited to preventative maintenance, corrective maintenance, predictive data collection in a GxP environment using site CMMS.
• Lead and support site investigations, identifying root cause identify measures to prevent recurrence.
• Participate in FATs and SATs for manufacturing equipment
• Set up and deliver training for the maintenance of manufacturing equipment to be delivered to the sustaining team.
• 3rd level qualification in an Engineering, technical discipline or equivalent.
• 5-7 years’ experience in biotechnology and/ or pharmaceutical industry or equivalent.
• A good understanding of manufacturing processes, maintenance, and reliability best practices.
• CQV experience in a post IQ/OQ environment.
• Understanding of compliance documentation and processes
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.
• The candidate will have strong problem solving and trouble shooting skills.
• The candidate will have experience with Biotech manufacturing equipment.
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