Instr Engineer Level II Charleston United States,
As an Instructional Engineer Level II you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at Alcami is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing. You will perform autonomous execution of tasks associated with the calibration of equipment and instrumentation site wide.
Essential Job Functions:
- Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including, calibration, safety, lock outs, etc.
- Calibrate, troubleshoot, and repair various types of instrumentation including, pressure, temperature, flow, and humidity.
- Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for calibration activities.
- Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.
- Maintain calibration equipment along with their certification records.
- Read and interpret diagrams, drawings, and other schematics.
- Provide leadership, development, and mentoring for others.
- Attend inter-departmental meetings to discuss matters involving the coordination of calibration activities.
- Answer compliance and process questions from others.
- Communicate policies and procedures to employees.
- Gather, organize, and communicate operational information to others.
- Assist others in investigations and studies.
- Identify temporary and permanent fixes to address issues.
- Report process deviations when they occur.
- Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
- Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
- Provide "off shift" support (for example: night shift support if you normally work day shift).
- Assign work tasks and activities to others.
- Prepare regular and ad hoc reports for others.
- Provide 24/7 "on-call" support to others.
- Review technicians' calibrations.
- Train others on systems, software, equipment, machines, and procedures to support calibration activities.
- Fill in for immediate supervisor when absent.
- Interact with regulatory agency personnel during audits and inspections as required.
- Facilitate inter-departmental meetings to discuss matters involving the coordination of calibration activities.
- Participate in cross-functional teams to meet strategic goals.
- Attend team meetings to discuss progress, initiatives, and/or other matters.
- Perform preventative (scheduled) and corrective/emergency (unscheduled) maintenance of equipment, systems, and/or facilities without supervision.
- Facilitate supplier relationships.
- Serve as SME (subject matter expert) for calibration activities.
- High school diploma or equivalent and previous experience in a regulated or cGMP environment.
- Associate’s degree in a technical discipline or certification in a related area.
- 7 years of experience in calibration, electronics, or related area.
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