The Sterile Operations Maintenance Technician provides essential maintenance and technical support to manufacturing across the full range of sterile manufacturing equipment. The role involves developing preventative maintenance (PM) routines, completing PMs on time in addition to reacting to machine breakdown to support manufacturing performance. The role also plays a significant role in ensuring all equipment related documentation meets the cGMP standards expected.

Sterile Operations Maintenance Technician

Key Duties and Responsibilities:

• Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
• Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment – champions safe working always.
• Provides maintenance support as required to include process systems, filling equipment, preparation equipment and clean utilities. Can provide basic automation and instrumentation support and liaises with automation/instrumentation specialists when required.
• Uses structured problem solving in the event of equipment failure and documents all equipment interventions as required by the maintenance system.
• Prepare preventative maintenance (PM) routines with other technical colleagues to minimise the risk of machine failure or equipment related deviations.
• Completes PM routines on time.
• Is trained and qualified to work in a grade B cleanroom and maintains this qualification.
• Is disciplined in ensuring personal hygiene at all time, and in following the garbing and hygiene expectations of working in a sterile manufacturing environment.
• Participates in bi-annual media fill studies to maintain qualification status.
• Is diligent in the completion and review of maintenance and related documentation required to meet GMP requirements of a sterile manufacturing site.
• Participates in and can lead continuous improvement teams. Proposes improvement ideas.
• Takes ownership of manufacturing equipment performance and builds relationships with key OEM support contacts.

• Familiar with pharmaceutical equipment and systems such as CIP/SIP, autoclaves, filling machines, isolators, clean utilities.
• Strong technical, troubleshooting and problem solving skills.
• Proficient in use of Microsoft Office and other computer applications i.e. CMMS.
• Strong team player with good proactive approach & manner
• Knowledgeable of the regulatory and GMP requirements for maintenance activities.
• Degree/Diploma and/or technical certification / trade in a mechanical, electrical or related field.
• Experience performing maintenance on process equipment in a cGMP commercial environment, preferably with experience working in a cleanroom environment.

• Ideally trade qualified in mechanical fitting or as an electrician.

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