Facilities Compliance Mgr Engineer

Amgen • Holly Springs, NC

18h • $110,928 - $150,080

About The Position

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. 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, 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.
FACILITIES COMPLIANCE MGR ENGINEER
What you will do
Let’s do this. Let’s change the world. In this vital role you will ensure facility systems, maintenance programs, engineering activities, and quality processes consistently meet cGMP requirements, Amgen standards, and global regulatory expectations. In this critical 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.
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.

Requirements

• 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

Nice To Haves

• 5+ years supporting Facilities & Engineering in a GMP-regulated biotechnology or pharmaceutical environment.
• Demonstrated expertise in Facilities Quality & Compliance.
• Extensive experience owning Deviations, CAPAs, Change Controls, and Risk Assessments.
• Strong knowledge of FDA cGMP regulations, engineering lifecycle management, and inspection readiness.
• Experience supporting FDA, EMA, and regulatory inspections.
• Working knowledge of HVAC, Cleanrooms, Critical Utilities, BMS, Environmental Monitoring, Maximo, Commissioning, and Qualification.
• Strong project management and stakeholder management skills.
• Excellent technical writing, analytical thinking, and structured problem-solving capabilities.
• Continuous Improvement mindset utilizing Lean, Six Sigma, or Operational Excellence.
• Highly proactive with exceptional customer service, communication, and collaboration skills.

Responsibilities

• 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.
• 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.
• 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).
• 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.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED