The Maintenance Technician IV is responsible for performing advanced repairs and preventative maintenance activities on cGMP process equipment, utility systems, and facilities as directed. The Maintenance Technician IV is also responsible for the operation of plant utility equipment, and cGMP utility equipment.
Under limited supervision the successful candidate will be able to:
- Perform corrective and preventative maintenance activities primarily on manufacturing process equipment and critical utility systems.
- Troubleshoot equipment as necessary, working with end users, engineers and equipment vendors. Takes the lead role in developing solutions for equipment issues.
- Maintain operation of cGMP utility equipment, such as HVAC, Water for Injection and Clean Steam systems.
- Maintain operation of plant utility equipment such as boilers, compressors and water systems.
- Partner with EHS and Quality Operations to create a strong culture of compliance.
- Perform document revisions as required to operation and maintenance procedures.
- Become subject matter expert on designated systems/equipment and train junior personnel
- Maintain cGMP records, both paper-based and electronic.
- Provide “on-call” support on a rotating basis as required.
- Respond to alarms and document activities.
- Other duties as required.
- 8+ years’ experience working in a cGMP environment.
- Experience performing repairs on production and/or utility equipment such as parts washers, autoclaves, bioreactors, ultra-filtration skids, chromatography skids, WFI stills, cleanroom HVAC systems, clean steam generators.
- Experience utilizing CMMS (Infor, Maximo, Blue Mountain, etc.) a major plus.
- Proficient using Trackwise to manage deviations and CAPAs.
- Strong written and verbal communication skills.
- Post-secondary degree in a science/technical field or a technical trade school degree preferred.
- Military training equivalent of above is acceptable.
- Relevant work experience may also be considered.
Smithfield, RI, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.