Principal Engineer, Process Inst. & Cont
Description
To be a technical subject matter expert in assessing instrument calibrations compared to engineering/user requirements, and to provide hands‑on and/or formal training for calibration, engineering, and end users as needed.
Duties & Responsibilities
- Position will act as a subject matter expert and bridge the gaps between calibration evaluations for entry into the CMS, vs. end user or engineering defined specifications.
- Position will perform/assist in development of/or revision of existing calibration procedures.
- Position will provide a high level of technical expertise in assisting and performing assigned Out of Tolerance investigations, CAPAs, to help identify root cause analysis, in depth troubleshooting, and providing appropriate actions.
- Position will perform on hands and/or formal training as needed for usage and calibrations with calibration technicians, site services, and end users.
- Position may at times be required to act as a management backup for various electronic systems, such as CMMS, CMS, Ereq system, Trackwise, etc. This will include reviewing and approving various calibration documentation and work orders performed by others.
- Position will drive the BIAH calibration group change control process, by working with end users, engineering, maintenance, and vendors to upgrade obsolete instrumentation, or to assist in identifying more appropriate instrumentation for current processes.
- Position may at times due to shutdowns, technician leaves of absence, and/or to avoid production schedule interruptions, will perform calibration.
- Position will perform assigned team member project work such as BIgCAL program, or new processes moving into the plant.
- All work will be performed by cGxP guidelines, BIVI safety programs.
Requirements
- Bachelor’s degree from an accredited institution with 10 years experiences working in calibration/PLC and microprocessor fields, preferably in a Pharma environment.
- Must have a well‑established background in performing both hands on, and creation of formal training plans.
- Advanced troubleshooting skills.