Compliance System Owner

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. 

Compliance System Owner

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the system owner responsible to oversight all compliance aspects at the Inspection lines. 

• Support or Lead on Deviations, CAPAs, Technical Assessments, Change Controls, Periodic Reviews and Internal/External Audits

• Lead and execute corrective and preventive actions to enhance engineering controls on the manufacturing processes. Including the Effectiveness Verification of actions

• Conduct root cause analysis and document findings

• Develop and execute equipment testing protocols and analyze data to support investigations

• Review and update documentation such as validation protocols, design documents, SOPs, and data integrity assessments

• Collaborate with peers to ensure quality and compliance of documents. Review and revisedocuments including data integrity and security assessments, validation protocols and reports, design documents and SOPs.

• Create and refine engineering policies and procedures impacting multiple departments

• Apply engineering principles and advanced techniques to develop creative technical solutions

• Manage equipment lifecycle and maintenance using Maximo (create, execute, and approve work orders)

• Work with cross-functional teams (e.g., QA, Validation, Facilities) to define system/facility modifications

• Partner with project managers to ensure projects meet scope, schedule, budget, and quality goals

• Coordinate work with external consultants, engineers, and vendors

• Engage with vendors to troubleshoot equipment issues and implement improvements

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The System Owner - Compliance professional we seek is an individual contributor with these qualifications. 

Basic Qualifications:

Master’s degree in Engineering

OR

Bachelor’s degree and 2 years of Engineering experience

Preferred Qualifications:

• Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry

• Familiarity with inspection equipment, process characterization, validation, monitoring, and optimization techniques 

• Strong problem-solving skills and experience conducting root cause investigations

• Expertise in identifying and managing Corrective and Preventive Actions (CAPAs)

• Knowledge of parenteral inspection processes

• Familiarity with inspection equipment, process characterization, validation, monitoring, and optimization techniques

• Proficiency in statistical analysis and Design of Experiments (DOE) methodologies

• Ability to apply engineering principles to solve technical issues in a production environment

• Experience developing solutions to routine technical problems of limited scope

• Proficiency in technical report writing

• Effective communication skills in both Spanish and English (verbal and written)

• Availability to support non-standard shifts, including extended hours, nights, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

careers.amgen.com

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Sponsorship

Sponsorship for this role is not guaranteed.

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.