Engineer

BioSpace; Thousand Oaks (CA); On-site; USD 103,000 - 118,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus eligibility

Job summary

Amgen seeks a mechanical/biomedical/engineering professional to support the development, qualification, and validation of GMP test methods for vials, prefilled syringes, and injection devices. You will implement projects per established procedures, identify risks, and provide technical support across product lifecycles.

Telecommuting may be available. The role requires a Master’s degree in engineering and at least 1 year of related experience, plus familiarity with SAP, Trackwise, Minitab,

Qualifications

• Masters degree in an engineering field and one year of experience in related occupation.
• Familiarity with industry standards (ASME Y14.5, ISO, CFRs) and GMP/GDP regulatory environments.
• Experience with quality systems and GMP validation practices in biopharmaceutical manufacturing.
• Experience with SAP, Trackwise, Minitab, Maximo, or Smartsheet and design/prototyping tools such as SolidWorks or GrabCAD.
• Knowledge of validation protocols and documentation practices including change control and CAPA.

Responsibilities

• Support develop, qualify, and validate GMP test methods for vials, prefilled syringes, and injection devices.
• Coordinate test method development, design characterization, verification, and delivery with contractors to meet product assembly requirements.
• Assist with cost estimation for new processes, gauges, and equipment development; support capital request documentation.
• Author test method execution documents and gather requirements for safe equipment operation; ensure risk mitigation and timeline alignment with partners.
• May telecommute and support project lifecycles with clear communication across teams.

Education

Masters degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or related field

Tools

SAP

Trackwise

Minitab

Maximo

Smartsheet

SolidWorks

GrabCAD

Polyjet 3D Printing

Job description

Join Amgen Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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:

Masters 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 preventive actions (CAPA).

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.

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, well 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

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.