
Senior Systems Integration Specialist
2 weeks ago
The role of Senior/Principal Instrumentation Engineer involves specifying instrumentation for biopharmaceutical process & utilities systems and supporting all aspects of the site calibration program.
- Evaluates new instrumentation for functional equivalence to existing instrumentation.
- Supports authoring and maintains configuration specifications & standards for cGMP manufacturing instrumentation.
- Understands common process & utilities instrumentation including load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors.
- Works with technical SME for the site calibration program, providing technical guidance to calibrations operations team and supporting regulatory body inspections and audits.
- Instrumentation Evaluation: Evaluates new instrumentation for functional equivalence to existing instrumentation.
- Configuration Standards: Supports authoring and maintains configuration specifications & standards for cGMP manufacturing instrumentation.
- Process Understanding: Understands common process & utilities instrumentation including load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors.
- Technical Support: Works with technical SME for the site calibration program, providing technical guidance to calibrations operations team and supporting regulatory body inspections and audits.
Additional responsibilities include implementing corrective/preventative actions for existing instrumentation, conducting troubleshooting and root cause analysis for complex instrumentation and associated systems, creating and maintaining configuration specifications for cGMP manufacturing instrumentation, assisting in the design review of equipment, and reviewing and approval of wiring diagrams for instrumentation & associated control systems.
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