Engineer

Amgen; Thousand Oaks (CA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking an Engineer to support the development, qualification and validation of GMP test methods for vials, prefilled syringes and injection devices. You will coordinate with contractors, ensure design verification and qualification, and assist with CAPA and risk assessment to strengthen manufacturing processes.

The role requires a Master’s degree in engineering and at least one year of related experience, with familiarity across GMP, GDP, ISO standards, and industry tools like SAP,

Qualifications

• Master’s degree in Mechanical, Biomedical, Electrical Engineering or related field and 1 year relevant experience.
• Knowledge of ASME Y14.5, ISO standards, and CFRs in regulated biopharmaceutical environments.
• Experience with GMP, GDP or GEP as they apply to manufacturing processes, facilities, or equipment.
• Familiarity with SAP, Trackwise, Minitab, Maximo, Smartsheet; design/prototyping tools like SolidWorks/GrabCAD/Polyjet.
• Experience validating protocols and documentation following change control and CAPA processes.

Responsibilities

• Support development, qualification and validation of GMP test methods for vials, syringes and injection devices.
• Coordinate test method development, design characterization, verification and delivery with contractors.
• Assist in risk assessment, CAPA, investigation support and change control for process improvements.
• Prepare and review documentation per GDP and quality systems; ensure timely project lifecycle execution.

Skills

GMP knowledge

ASME Y14.5 familiarity

GEP/GDP understanding

Problem solving

Education

Master’s degree in Mechanical/Biomedical/Electrical Engineering or related field

Tools

SAP

Trackwise

Minitab

Maximo

Smartsheet

SolidWorks

GrabCAD

Polyjet 3D Printing

Job description

Join Amgen’s Mission of Serving PatientsAt 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. 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).

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
  

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