Process Analytical Engineer

Responsibilities

• 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.
• 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.
• Develop laboratory equipment specifications to use for procurement of new laboratory equipment and instruments.
• Maintain a current working knowledge regarding regulatory requirements for equipment qualification and calibration.
• Support in generation and resolution of protocol discrepancies as required.
• Alert Quality Control Management if equipment fails to meet calibration or qualification requirements and conduct 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.
• Write/contribute to equipment operating procedures and manuals.
• Design and conduct training for manufacturing staff, and other department staff as applicable.
• Own and project manage change controls while meeting applicable change control metrics.
• Prepare and present 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.

Qualifications

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