Purpose: The Calibration Engineer supports the Calibration Lead in overseeing a team of calibration technicians, including both external contractors and internal staff, to perform verifications and inspections of field instruments and devices. This role entails managing all content related to Calibration Job Plans and data within the Computerized Maintenance Management System, as well as analyzing data to identify opportunities for continuous improvement.
Major Responsibilities:
- Assign and schedule Calibration work orders and requests for support.
- Ensure all calibration work complies with approved SOPs and cGMP standards, including timely follow-up on work orders, change controls, investigation reports, and deviations.
- Assist in the review of calibration documentation, including Test Methods, SOPs, Process and User Requirements (PURs), and calibration data sheets.
- Review and approve the content of work orders upon completion to ensure compliance with GMP and technical accuracy.
- Serve as a key technical resource for troubleshooting all instruments in the facility.
- Participate in and assist the Calibration Lead with addressing deviations, variances, and OOT investigations as needed.
- Ensure reference standards remain in a valid calibrated state.
- Collaborate with other engineering personnel to improve equipment troubleshooting methods.
- Assess current systems and procedures, propose alternative solutions as needed, and recommend implementation plans to meet business and regulatory requirements.
- Supervise Calibration Technicians responsible for supporting manufacturing unit operations.
- Provide support to plant operations on an on-call basis beyond working hours, ensuring total compliance with cGMP and safety standards with minimal equipment and systems downtime.
- Schedule the availability of Calibration personnel to guarantee 24/7 coverage (on-site and on-call).
- Develop and assist in implementing training programs for Calibration staff.
- Support Project Engineering by completing projects requiring instrumentation calibration and change control support.
