Senior Engineer - Compliance System Owner (Inspection)

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.

SENIOR ENGINEER - COMPLIANCE SYSTEM OWNER (INSPECTION)

What you will do

Let’s do this. Let’s change the world! In this vital role you will serve as the Compliance System Owner for inspection lines, leading complex compliance strategies and technical resolution activities. As a senior technical leader, you’ll drive system lifecycle management, regulatory readiness, and performance optimization to ensure high-impact, sustainable outcomes in a GMP-regulated environment.

You’ll apply advanced engineering and compliance expertise, coordinate multi-functional initiatives, and serve as the primary subject matter expert (SME) for compliance systems—ensuring alignment with evolving industry standards and internal quality objectives.

Responsibilities include but are not limited to:

• Serve as System Owner for compliance aspects of inspection lines, ensuring system integrity, performance, and audit readiness
• Lead and close complex Deviations, CAPAs, Technical Assessments, Change Controls, Periodic Reviews, and support internal/external audits
• Design, implement, and analyze equipment testing protocols to support investigations, validation, and risk-based decision-making
• Lead cross-functional root cause analyses and develop strategic, data-driven corrective/preventive action plans
• Provide technical leadership in the implementation and effectiveness verification (EV) of CAPAs
• Review, revise, and approve documentation such as validation protocols/reports, SOPs, data integrity assessments, and design documentation
• Develop and refine engineering policies and procedures that impact multiple organizational units
• Employ advanced engineering techniques and apply cross-disciplinary expertise to develop innovative, long-term solutions
• Manage the equipment lifecycle through Maximo or equivalent systems, including work order creation, execution, and performance tracking
• Act as a technical liaison with vendors to resolve equipment issues and introduce enhancements that support inspection system reliability
• Collaborate across functions (QA, Validation, Facilities, Mfg, Process Development) to define and implement complex system/facility modifications
• Partner with project managers to ensure compliance-focused projects meet scope, budget, and schedule goals
• Lead coordination with external consultants, architects, and engineering firms to ensure standard design compliance and engineering excellence
• Act as SME during regulatory audits and compliance assessments, proactively addressing gaps and ensuring inspection readiness
  

What we expect of you

We are all different! Yet, we all use our outstanding contributions to serve patients. The Senior Engineer professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 2 years of Engineering experience

OR

Bachelor’s degree and 4 years of Engineering experience

Preferred Qualifications:

• 6+ years of engineering experience in GMP-regulated pharmaceutical, biotech, or medical device environments
• Demonstrated ability to lead cross-functional investigations and close high-impact compliance events
• Expertise in root cause analysis, CAPA systems, and audit readiness
• Knowledge of parenteral inspection processes, inspection equipment, and data integrity practices
• Experience with validation lifecycle activities, including protocol development, test execution, and documentation
• Proficiency in statistical analysis, DOE methodologies, and engineering problem-solving tools
• Strong project leadership skills and ability to manage multiple priorities
• Skilled in technical report writing and bilingual communication in Spanish and English
• Availability to support non-standard shifts including extended hours, weekends, and holidays
  

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 and an annual site shutdown
• Flexible work models, including remote work arrangements, where possible
  

Apply now and make a lasting impact with the Amgen team.

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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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.