Process Analytical Engineer

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Amgen, a leader in biopharmaceuticals, is seeking a Process Analytical Engineer to join the North Carolina facility. You will plan, execute, and document qualification and maintenance of laboratory systems, troubleshoot analytical equipment, and support validation activities for cGMP compliance.

This role partners with manufacturing to improve equipment uptime and ensure regulatory readiness, including data integrity and system lifecycle documentation across projects and sites.

Qualifications

• Masters degree required or equivalent combination of education and experience.
• Bachelor's degree in engineering or related technical field or equivalent.
• Associates degree with relevant cGMP lab experience or high school with extensive experience may be considered.

Responsibilities

• Plan, execute, and document qualification, calibration, and routine maintenance of laboratory systems for cGMP QC facilities.
• Perform troubleshooting and root cause analysis for analytical equipment and coordinate vendor support.
• Manage calibration, maintenance, and requalification activities in Maximo CMMS.
• Develop and approve validation life cycle documents for computer-related systems, including data integrity testing.
• Support commissioning and system lifecycle documentation to maintain compliance and readiness.
• Collaborate with manufacturing to improve equipment uptime and reliability.

Skills

cGMP laboratory experience

Analytical instrument validation

Process engineering experience

Education

Master's degree

Bachelor's degree in engineering or related technical field

Associates degree

High school diploma / GED

Job description

ProcessAnalyticalEngineer

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. 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

ProcessAnalyticalEngineer

What youwill do

In this vital role, you will join the Facilities & Engineering (F&E) group andbe responsible forplanning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina (ANC). This role includes hands‑on troubleshooting and root cause analysis for analytical and laboratory systems, coordination of vendor support and repairs, execution and tracking of calibration, maintenance, and requalification activities through the Computerized Maintenance Management System (CMMS) Maximo, and direct support for manufacturing operations to improve equipment uptime and reliability. You will also author, own, and approve Validation Life Cycle documents for computer‑related systems, including responsibility for Data Integrity testing and business administration of laboratory computer‑related systems.

Support commissioning, qualification, validation, and system lifecycle documentation tomaintaincompliance and operational readiness.

Partner closely with manufacturing teams to resolve issues, improve system reliability, and minimize operational downtime.

Key Responsibilities

• System ownership, reliability, and operations
• Work with the capital project team to ensure systems are installed andoperatesafely,comply withpertinent environmental health and safety practices, rules, and regulations, and meet Amgen global engineering and design requirements.
• Serve asSystemOwner and Business Administrator foranalyticalequipment.
• Lead or work with teams in design, development andselectionof new systems, instruments, calibrationcapabilitiesand consumable components.
• Development of laboratory equipment specifications touse for procurement of new laboratory equipment and instruments.
• Maintaining a current working knowledgeregardingregulatory requirements for equipment qualification and calibration.
• Support in generation and resolution of protocol discrepancies asrequired.
• Alerting Quality Control Management if equipmentfails tomeet calibration or qualification requirements and conducting impact assessments/investigations asrequired.
• Lead the development of calibration/maintenance programs, ensure the availability of spare parts, schedule repairs and maintenance, and coordinate maintenance execution to keep systems in proper working order and minimize disruption to laboratory activities.
• Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures.
• Evaluatethe capabilitiesof current and potential suppliers, and assessnew technologiesthat could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
• Writing/contributing to equipment operating procedures and manuals.
• Designing and conducting training formanufacturingstaff, and other department staff as applicable.
• Own and project manage change controls while meeting applicable change control metrics.
• Preparing and presenting periodic management updates on activities to senior management.
• Conduct periodic reviews of instrument validation as part of validation life cycle.

Validation, compliance, and quality systems

A key contributor to Data Integrity Assessments for Lab systems

Support Amgens laboratory systems validation and Data Integrity philosophy during audit interactions.

Supportadditionaltasks andprojects asassigned by management.

Cross-functional support, projects, and continuous improvement

Develop, coordinate, analyze, and present results for operational issues and engineering projects

Provide technical supportforcommercial and clinical manufacturing as needed.

Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.

Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.

Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and support interactions with regulatoryinspectorsas necessary.

Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.

Monitor systems toidentifyperformance risks and implement risk reduction strategies.

Provide troubleshooting support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation ofcorrective/preventive action; support may berequiredoutside of normal working hours, including nights, weekends, and holidays.

Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

Advance the use of condition-based and predictive maintenance practices by incorporating advanced data analytics where applicable.

Lead investigations of abnormal conditions through Deviation and related business processes.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications

• Masters degree
• OR
• Bachelors degree and2years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience
• OR
• Associates degree and6years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience
• OR
• High school diploma / GED and8years ofcGMP laboratory,analytical instrument validation, and/or Process Engineerexperience

Preferred Qualifications

• Bachelors degree in engineering or related technical field
• Laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.