The Engineering Services Department is responsible for all day to day engineering support activities at Alexion’s Rhode Island Manufacturing Facility (ARIMF) for commercial and clinical products. Our responsibilities include process engineering, facilities, and utilities engineering. The department is also the owner of clean-in-place (CIP) and sterilize-in-place (SIP) design, equipment, and general engineering procedures. Our goal is to ensure that all site GMP equipment performs predictably and continues to function as designed in order to support the manufacturing operations and meet the patient needs of our products. This Engineer II position will focus on supporting the upstream and downstream portions of the Soliris® process including the cell culture, media preparation, purification suites, buffer preparation, and buffer hold operations.
- Provide direct engineering support for manufacturing operations in the commercial and clinical manufacturing areas. This support includes being the owner of the GMP equipment and systems in the area to include troubleshooting mechanical equipment to determine root cause of failure modes, owning Corrective/Preventative Actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
- Develop a deep knowledge of the operations of the equipment in the manufacturing area including the automated processes including CIP, SIP, and processing.
- Foster a strong safety culture by proactively evaluating the operational safety of manufacturing equipment and propose and implement safety improvements. Additionally, must work in a safe manner at all times by adhering to all safety procedures and have a proactive safety mindset.
- Drive project teams through all phases of engineering projects in the manufacturing area including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
- Work with stakeholders to expedite equipment return to service for equipment
- 2-5 years of relevant experience in a commercial biopharmaceutical manufacturing environment
- Good familiarity with biotechnology operations, including GMPs. Knowledge of manufacturing unit operations such as cell culture, chromatography and ultrafiltration is preferred.
- Excellent interpersonal and communication skills (verbal and written) are required. Technical writing skills required.
- Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions.
- Familiarity with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.
- Ability to interact well with other groups and work independently on assigned tasks. Must be able to take ownership of and follow through on assignments
- BS in Chemical or Mechanical Engineering or related engineering discipline.
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