Instrument Engineer
Core
Design, specify, and maintain cGMP process instrumentation and manufacturing equipment to support life-changing medicine production.
Role type
Instrument Engineer (cGMP manufacturing)
Builds
cGMP manufacturing equipment and process instrumentation
Domain
Biopharmaceutical manufacturing
Required skills
cGMP process instrumentation, project management, root cause analysis, calibration justification, equipment design review, test plan execution, corrective/preventative actions, engineering evaluations, supplier list management, change control documentation
Preferred skills
Biopharmaceutical process equipment experience, process control systems and automation
Technologies
Load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers, level sensors, automated systems
Responsibilities
Operate as a project manager to plan and execute projects within scope, time, and budget; Specify cGMP process instrumentation, components, and spare parts; Set priorities for and complete Calibration Range and Tolerance Justifications forms; Evaluate new instruments for Functional Equivalence to obsolete instrumentation; Review and approve input/output lists for automated systems; Conduct troubleshooting and root cause analysis for complex instrumentation; Create and maintain configuration specifications for cGMP manufacturing equipment; Assist in the design review of equipment and approved supplier lists; Write and execute test plans to demonstrate instrument suitability; Implement corrective/preventative actions for existing equipment; Prepare engineering evaluations and test plans for change control documentation; Possibly supervise engineering contractors
Seniority
Entry to Mid-level, hands-on IC
