Senior Engineer System Owner Compliance

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical / dental / vision

Stock-based incentives

Bonus program

Flexible work model

Job summary

Amgen in Holly Springs, NC seeks a Senior Engineer, System Owner Compliance to ensure GMP-compliant facility systems and robust quality programs. You will partner across Facilities, Manufacturing, Quality, Validation, EHS, and Supply Chain to maintain inspection readiness and drive continuous improvement.

The role requires strong engineering judgment, regulatory knowledge, and hands-on leadership in deviations, CAPAs, change controls, and risk mitigation to optimize reliability and compliance in

Qualifications

• Bachelor’s or higher degree in engineering or related field.
• Strong knowledge of cGMP, GMP, and quality systems.
• Experience leading deviations, CAPAs, and change controls.

Responsibilities

• Own facility-related Deviations from initiation to closure and lead investigations.
• Lead CAPAs and determine effectiveness verification.
• Own and manage change controls and deviations.
• Monitor quality metrics and mitigate risks.
• Support audits and regulatory inspections.
• Drive continuous improvement initiatives using Lean, Six Sigma, and data-driven methods.
• Partner with Manufacturing, Quality, Validation, EHS, Supply Chain, and Engineering.

Skills

Engineering judgment

Ownership

Technical leadership

Regulatory knowledge

Root cause analysis

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

CAPA tracking systems

Change control systems

Job description

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE

What you will do

Lets do this. Lets 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
• Associates degree and 8 years of Engineering experience OR
• Bachelors degree and 4 years of Engineering experience OR
• Masters degree and 2 years of Engineering experience OR
• Doctorate degree

Preferred Qualifications

• Bachelors 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, 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.

Benefits

• 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. Refer to the Work Location Type in the job posting to see if this applies.
• Work/life Balance

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.

Sponsorship

Sponsorship for this role is not guaranteed.

Inclusion and Diversity Statement

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.

Equal Opportunity Statement

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.

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.