Engineer
About The Position
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Engineer Duties: Support develop, qualify, and validate Good Manufacturing Practice (GMP) physical test methods for vials, prefilled syringes, and injection devices; Implement projects per Combination Products Operations and company procedures to ensure timely and budget-conscious completion; Identify issues and risks and provide experienced support for investigations, Corrective Action Preventive Action (CAPA), Root Cause Analysis and new process development to enhance manufacturing operations; Coordinate test method development, design characterization, design verification and delivery with contractors while ensuring qualification parameters for product assembly requirements are met; Support cost estimation for new processes, gauges, and equipment development, aiding in capital request documentation; and Author test method execution documents, gather requirements for safe equipment operation, and drive effective communication and integration for optimized decision-making throughout project lifecycles, including risk mitigation and timeline alignment with partners and vendors. May telecommute.
Requirements
- Master’s degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or related field and one year of experience in the job offered or engineer-related occupation.
- 1 year of experience in Industry standards and guidelines including ASME Y14.5, ISO standards, and CFRs
- 1 year of experience in Regulated environments including: Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP), or Good Documentation Procedures (GDP) as they apply to biopharmaceutical manufacturing processes, facilities, or equipment
- 1 year of experience in Historian and business supporting systems including: SAP, Trackwise, Minitab, Maximo, or Smartsheet
- 1 year of experience in Design and prototyping including: SoildWorks, GrabCAD, or Polyjet 3-Dimensional printing
- 1 year of experience in Supporting pharmaceutical validation protocols and practices related to manufacturing process, analytical method, or facility equipment and system
- 1 year of experience in Document and review methods, protocols, reports, and project plans following GDPs and quality systems or processes such as change control, and corrective and preventative actions (CAPA)
Responsibilities
- Support develop, qualify, and validate Good Manufacturing Practice (GMP) physical test methods for vials, prefilled syringes, and injection devices
- Implement projects per Combination Products Operations and company procedures to ensure timely and budget-conscious completion
- Identify issues and risks and provide experienced support for investigations, Corrective Action Preventive Action (CAPA), Root Cause Analysis and new process development to enhance manufacturing operations
- Coordinate test method development, design characterization, design verification and delivery with contractors while ensuring qualification parameters for product assembly requirements are met
- Support cost estimation for new processes, gauges, and equipment development, aiding in capital request documentation
- Author test method execution documents, gather requirements for safe equipment operation, and drive effective communication and integration for optimized decision-making throughout project lifecycles, including risk mitigation and timeline alignment with partners and vendors
Benefits
- stock
- retirement
- medical
- life and disability insurance
- eligibility for an annual bonus or for sales roles, other incentive compensation
- health and welfare plans for staff and eligible dependents
- financial plans with opportunities to save towards retirement or other goals
- work/life balance
- career development opportunities
- Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
