The Company
Amgen recently acquired Horizon Therapeutics. We are excited to join forces, drawing on our unified expertise and shared mission to deliver first-in-class medicine to patients around the world suffering from serious illness.
Position Summary:
As a Maintenance Technician, you'll play an important role in being a maintenance subject matter expert in all systems associated with the Sterile Fill Finish Operation. You will also have responsibilities to maintain equipment/systems in non-GMP areas that are critical to the manufacturing process.
Please note this is a shift position. The role will also be required to support an on-call roster.
Qualifications and Skills Required:
- Fully qualified to National Craft Standard or equivalent 3rd Level Qualification
- Minimum 2 years' maintenance experience in the Biopharmaceutical industry or similar cGMP manufacturing experience (API, OSD, Med Device, Infant Formula, etc)
- Multi-skilled - Primarily Electrical with an understanding of Calibration and Instrumentation. Basic mechanical knowledge would be an advantage also.
- Desirable equipment experience: Vial / PFS Fill Line, Isolator, CLU, Autoclave, Parts Washer, Inspection Machine, Lyophiliser, HVAC, WFI / PUW, Process Air / Nitrogen, Safety & Electrical (MV / LV) Systems.
- Experience with problem-solving skills, troubleshooting, and setup of process equipment.
- Ability to interpret P&IDs, equipment/system layouts, wiring & pneumatic diagrams, etc.
- Must be knowledgeable of the GMP regulatory requirements for maintenance activities.
- Proficient in the use of CMMS, experience in PEMAC, MAXIMO or SAP PM preferable.
- Operate and retrieve/interpret data from control systems (SCADA, QBMS, BMS).
- Audit experience providing technical assurance, (FDA, HPRA, EPA, etc) advantageuous.
- Experience in drafting SOPs, WIs and PMs would be an advantage.
- Proficient in the use of Microsoft Office and other computer applications.
- Excellent interpersonal, written and verbal communication skills.