Career CategoryEngineering
Job DescriptionEngineer 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. Position requires 1 year of experience in the following:
Industry standards and guidelines including ASME Y14.5, ISO standards, and CFRs;
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;
Historian and business supporting systems including: SAP, Trackwise, Minitab, Maximo, or Smartsheet; Design and prototyping including: SoildWorks, GrabCAD, or Polyjet 3-Dimensional printing;
Supporting pharmaceutical validation protocols and practices related to manufacturing process, analytical method, or facility equipment and system; and
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).
Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-248078
Job type: Full Time position. The annual salary for this position in the U.S. is $102,679.00- $117,995.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/
What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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
Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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