Senior Engineer System Owner Compliance

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen Inc. in the United States is seeking a Senior Engineer, System Owner Compliance to lead engineering activities that support GMP manufacturing and inspection readiness.

You will partner across Facilities & Engineering, Manufacturing, Quality, Validation, EHS, Supply Chain, and Capital Projects to drive compliance and reliability. You will own Biopharmaceutical compliance programs, develop maintenance and qualification plans, lead investigations and CAPAs, and support capital projects

Job description

SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE

What you will do Let’s do this. Let’s change the world. In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness. The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service.

Provide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order. Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary. Monitor systems to identify performance risks and implement risk reduction strategies.

Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

Facilities Quality & Compliance

Serve as the technical lead for Facilities Quality & Compliance programs supporting GMP manufacturing operations. Ensure facility systems, utilities, maintenance programs, engineering activities, and documentation remain compliant with cGMP regulations, Amgen standards, and engineering requirements. Maintain Facilities & Engineering in a continuous state of inspection readiness through proactive compliance monitoring and risk mitigation. Partner with Quality Assurance during internal audits, corporate audits, customer audits, and regulatory inspections.

Quality Systems Ownership

Own facility-related Deviations from initiation through closure, including investigation leadership, root cause analysis, effectiveness verification, and timely implementation of corrective actions. Lead structured investigations using risk-based methodologies including 5-Why, Fishbone, Kepner-Tregoe, and Human Performance principles. Own engineering Change Controls, ensuring appropriate impact assessments, stakeholder alignment, and compliant implementation. Own & Manage Deviations from initiation through timely closure, ensuring sustainable corrective and preventive actions. Manage CAPAs from initiation through effectiveness verification, ensuring sustainable corrective and preventive actions. Monitor quality metrics, identify emerging compliance trends, and proactively mitigate risks.

Engineering & Maintenance Excellence

Support commissioning, qualification, startup, and lifecycle management of facility systems and utilities. Develop and approve engineering procedures, maintenance strategies, technical reports, and risk assessments, as needed. Ensure engineering documentation complies with Good Documentation Practices (GDP).

Continuous Improvement Champion

a continuous improvement mindset by simplifying processes, reducing compliance risk, improving equipment reliability, and enhancing operational performance. Lead improvement initiatives utilizing Lean, Six Sigma, Operational Excellence, and data-driven decision making.

Business Partnership

Build trusted partnerships across Manufacturing, Quality, Validation, EHS, Supply Chain, and Engineering. Demonstrate a proactive, customer service mindset by delivering responsive engineering solutions while balancing compliance, reliability, and business needs. Influence cross-functional teams without direct authority while fostering ownership, accountability, and collaboration.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Professional we seek is a person with these qualifications.

Basic Qualifications

• High school diploma / GED and 10 years Engineering experience OR Associate’s degree and 8 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Master’s degree and 2 years of Engineering experience OR Doctorate degree
• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Great teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
• Ability for domestic/international travel

Preferred Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Great teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
• Ability for domestic/international travel

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 where possible.

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.

Application deadline

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.

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 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.

Salary Range 115,494.60USD -156,257.40 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visitwww.amgen.com and followwww.twitter.com/amgen