Our commitment to serving patients lies at the heart of Amgen's success. As the world's largest biotechnology company, we discover, develop, manufacture and market therapies upon which thousands of people rely. And thousands of highly committed individuals from across the professional spectrum are involved in the complex, multifaceted process that takes an idea out of the laboratory and lets us bring it, in the form of a needed therapy, to patients. Bring your sense of commitment to Amgen and be part of this extraordinary process. We currently have the following opportunity at our Thousand Oaks, CA facility.Engineer II ?Pharmaceutics
Requirements:
Bachelor's degree in Engineering, Science or related technological field or equivalent combination of education and experience required. Typically 8 plus years of relevant work experience in operations/manufacturing environment with at least 5 plus years experience in the Pharmaceutical industry. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) is necessary. Additional comprehensive understanding of validation protocol execution requirements is needed, as well as a good understanding of solid dosage form manufacturing equipment as it relates to clinical pharmaceutical operations. Candidates should be able to understand and operate mechanical equipment exemplified by granulators, tablet press, fluid bed dryer, and other specialized laboratory equipment (valve, pump, replacement part, COP control system, electronic components, etc.) and computers as well as demonstrate an in-depth knowledge of validation processes and requirements as applied to new equipment installations. Additional requirements include a working knowledge of pharmaceutical processes and a detailed understanding of GMPs and CFRs in establishing current practices.
Job Summary:
Employee will assume system ownership for new and existing pharmaceutical process equipment and provide technical guidance and coordination for maintenance, calibration, upgrade, and revalidation of such equipment. Employee will also lead as a technical expert to troubleshoot and implement remedial actions for operational failures encountered in the operation of the Formulation Development Laboratory (FDL) equipment. He/she will apply advanced engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Additional responsibilities involve developing, organizing, analyzing and presenting interpretation of results for operational issues or related engineering projects. In addition, employee will routinely audit the operational performance and regulatory compliance of highly complex equipment systems and lead efforts within formulation development, utilities, facilities, quality assurance, validation department, and other Amgen groups in developing requirements and recommendations for system modifications. Additional responsibilities include developing project scopes, scheduling and budgeting within an area of expertise, and obtaining, comparing, and analyzing quotes for new/old equipment and/or system/facility modifications.
Amgenî–¸ outstanding compensation package features comprehensive benefits and relocation assistance. Come be a part of the big picture at Amgen.
Interested candidates please email resume to [email protected]
As an EEO/AA employer, Amgen values a diverse combination of perspectives and cultures. M/F/D/V
Pharmaceutical Engineer Opening at Amgen
Posted - 11/09/2005 : 4:03:53 PM
