Manufacturing Engineer II: Alexion Pharmaceuticals,Inc.

Responsiblities:

The Manufacturing Engineer II’s responsibilities include being the maintenance lead for large capital projects and PM review modification. The position will act as a liaison with the Engineering department in reviewing all new projects for long term maintenance needs. The incumbent will also be responsible for a majority of the Maintenance department’s technical writing and GMP documentation revisions. Detailed responsibilities are outlined below.

• Provide support to the Maintenance department serving as the technical writer to facilitate the development of SOP’s, commissioning documents, white papers, deviations and any other documentation as required by area management.

• Initiate the development and periodic review of SOP’s to ensure maintenance is performed in accordance with manufacturer’s recommendations and good maintenance practices while working in accordance with cGMP guidelines.

• Assist in the administration of the plant maintenance program. The incumbent will assist Maintenance management as necessary in the administration of the maintenance program. This may involve gaining additional expertise with specific types of equipment or systems and writing maintenance procedures.

• Apply engineering theory, practices and principles to determine root cause of equipment failures and to perform equipment performance evaluations.

• Improve operation uptime, efficiency and equipment reliability by periodically performing equipment performance evaluations to determine optimal PM intervals of equipment.

• Communicate any discrepancies or equipment failures to management in a timely manner. Provide clear and accurate details of equipment failures as well as viable options for repair to management for pre approval.

• Be available on a 24/7 basis to provide guidance and expertise to the Maintenance department staff and management.

• Good interpersonal skills are required, as is the ability to communicate well, both written and verbally. The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner.

Requirements

• BS Degree with at least 5 years experience in an FDA regulated, GMP manufacturing setting acting in an engineering capacity for maintenance improvements of equipment operation.

About Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris^(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal noctural hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.