Process Analytical Engineer
Core
Planning, executing, and documenting qualification, calibration, and maintenance of laboratory systems for cGMP Quality Control facilities; hands-on troubleshooting and root cause analysis for analytical systems.
Role type
Process Analytical Engineer (cGMP Laboratory Systems)
Builds
Reliable, compliant analytical laboratory systems and equipment for drug substance manufacturing
Domain
Biopharmaceutical manufacturing / Quality Control / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP laboratory operations, analytical instrument validation, root cause analysis, calibration program management, system lifecycle documentation, change control management, equipment specification development, data integrity testing, vendor coordination, risk assessment, technical training
Preferred skills
Engineering degree, biopharmaceutical testing methodology knowledge, regulatory compliance expertise, electronic record integrity understanding, predictive maintenance practices
Technologies
Computerized Maintenance Management System (CMMS) Maximo
Responsibilities
Lead or support design, development, and selection of new analytical systems and instruments; develop laboratory equipment specifications for procurement; maintain knowledge of regulatory requirements for equipment qualification and calibration; generate and resolve protocol discrepancies; alert management on calibration failures and conduct impact assessments; lead development of calibration/maintenance programs and spare parts availability; participate in technical project teams as subject matter expert on validation regulations; evaluate supplier capabilities and new technologies; write equipment operating procedures and manuals; design and conduct training for manufacturing staff; own and project manage change controls; prepare management updates; conduct periodic reviews of instrument validation; support Data Integrity Assessments; support audit interactions; provide technical support for commercial and clinical manufacturing; implement engineering-based improvements; monitor systems for performance risks; lead investigations of abnormal conditions through Deviation processes; advance condition-based and predictive maintenance practices.
Seniority
Mid-level to Senior, hands-on IC