Process Analytical Engineer (Biotech)

Location: Holly Springs, North Carolina, United States; onsite support for 24/7 operations may include nights, weekends, and holidays.

Company

Amgen develops, manufactures, and delivers biopharmaceutical treatments across oncology, inflammation, general medicine, and rare disease.

What you will do

• Plan, execute, and document commissioning, qualification, validation, calibration, maintenance, and requalification of cGMP laboratory systems.
• Serve as system owner and business administrator for analytical equipment and laboratory computer-related systems.
• Troubleshoot equipment and laboratory systems, perform root cause analysis, and implement corrective and preventive actions to improve uptime and reliability.
• Develop equipment specifications, calibration and maintenance programs, operating procedures, training materials, and validation life-cycle documentation.
• Lead change controls, deviation investigations, data integrity assessments, periodic validation reviews, and audit or regulatory inspection support.
• Collaborate with manufacturing, capital project, quality, vendor, and engineering teams on system upgrades, new technology introductions, and continuous improvement projects.

Requirements

• Master’s degree, or a bachelor’s degree plus 2 years of cGMP laboratory, analytical instrument validation, and/or process engineering experience.
• Alternatively, an associate degree plus 6 years of relevant experience, or a high school diploma/GED plus 8 years of relevant experience.
• Bachelor’s degree in engineering or a related technical field is preferred.
• Experience in a cGMP laboratory environment and knowledge of analytical instrumentation, biopharmaceutical testing techniques, equipment validation, and electronic record integrity are preferred.
• Ability to work with minimal direction, collaborate across functions, analyze complex problems, and provide rotating on-call coverage for nights and weekends.
• Flexibility to support 24/7 operations and travel domestically or internationally.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Opportunity to support a new drug substance manufacturing facility combining disposable technologies, stainless steel equipment, industry 4.0 capabilities, and sustainability initiatives.
• Competitive base salary and comprehensive total rewards aligned with local industry standards.
• Inclusive workplace with accommodations available for qualified individuals with disabilities.