Maintenance Technician, Sterile Ops
Overall Purpose:
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 in support of manufacturing performance. The role also plays a significant role in ensuring all equipment related documentation meets the cGMP standards expected.
Essential Duties, Functions 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.
- Supports capital projects throughout equipment lifecycle and supports process development projects and associated validation activities.
- Reports accurately on all equipment downtimes to build history of equipment performance.
- Is always prepared to escalate any safety, quality or performance risk observed.
- Participate in out of hours on call as required.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.