The Instrument Technician IV is responsible for calibration, replacement, and repair of instrumentation on cGMP process equipment, utility systems, and facilities support systems as directed.
Under limited supervision the successful candidate will be able to:
- Perform and document instrument calibration activities in accordance with PM schedule and applicable procedures, policies, and cGMP requirements.
- Repair/Replace instrumentation as required in accordance with plant procedures, policies, and direction of management.
- Troubleshoot equipment as necessary, working with end users, engineers and equipment vendors. Takes the lead role in developing solutions for equipment issues.
- Partner with EHS and Quality Operations to create a strong culture of compliance.
- Maintain plant calibration standards and equipment.
- Maintain cGMP records, both paper based and electronic.
- Other duties as required.
- 8+ years’ experience working in a cGMP or other highly regulated environment.
- Experience performing calibrations on production and/or utility equipment such as parts washers, autoclaves, bioreactors, ultra-filtration skids, chromatography skids, WFI stills and clean steam generators.
- Experience utilizing CMMS (Infor, Maximo, Blue Mountain, etc.) a major plus.
- Proficient using Trackwise to manage deviations, CAPAs and change controls.
- Strong written and verbal communication skills.
- Post-secondary degree in a science/technical field or a technical trade school degree in Instrumentation Technology or a related field.
- 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.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer