Process Analytical Engineer

Process Analytical Engineer  

What you will do 

In this vital role, you will join the Facilities & Engineering (F&E) group and be responsible for planning, 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 to maintain compliance and operational readiness. 

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

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Key responsibilities: 

• System ownership, reliability, and operations 

• Work with the capital project team to ensure systems are installed and operate safely, comply with pertinent environmental health and safety practices, rules, and regulations, and meet Amgen global engineering and design requirements. 

• Serve as System Owner and Business Administrator for analytical equipment. 

• Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.  

• Development of laboratory equipment specifications to use for procurement of new laboratory equipment and instruments.   

• Maintaining a current working knowledge regarding regulatory requirements for equipment qualification and calibration.  

• Support in generation and resolution of protocol discrepancies as required.  

• Alerting Quality Control Management if equipment fails to meet calibration or qualification requirements and conducting impact assessments/investigations as required.   

• 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.   

• Evaluate the capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.  

• Writing/contributing to equipment operating procedures and manuals.  

• Designing and conducting training for manufacturing staff, 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 Amgen’s laboratory systems validation and Data Integrity philosophy during audit interactions. 

• Support additional tasks and projects as assigned by management. 

• Cross-functional support, projects, and continuous improvement 

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

• Provide technical support for commercial 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 regulatory inspectors as necessary. 

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

• Monitor systems to identify performance risks and implement risk reduction strategies.  

• Provide troubleshooting support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation of corrective/preventive action; support may be required outside 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. 

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What we expect of you 

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

Basic Qualifications: 

• Master’s degree  

OR   

• Bachelor’s degree and 2 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience   

OR   

• Associate’s degree and 6 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience   

OR   

• High school diploma / GED and 8 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience   

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Preferred Qualifications: 

• Bachelor’s degree in engineering or related technical field  

• Laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.  

• Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.  

• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.   

• Demonstrated success in managing an equipment qualification or maintenance program.  

• Ability to provide On-Call support coverage nights and weekends, on a rotating basis.  

• Position requires strong written and verbal skills and the ability to work with minimum direction.  

• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.  

• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.  

• Ability to function within cross-functional teams and embrace a team-based environment.    

• Work schedule flexibility as required to support 24/7 operations. 

• Ability for domestic/international travel.