Oversee the Metrology Department to assure compliant operations. Measure, track and communicate critical calibration metrics. Communicate status to local management team. Review of all calibration work orders to assure proper range of calibration and accuracy/precision of the instruments. Schedule and provide direction to three (3) Metrology Technicians. Support manufacturing operation by being on call 24/7.
Lead all Metrology related NCR investigations and recommend corrective actions to assure improved instrument reliability. Serve as the cross functional leader in these investigations. Lead RC/CAPA efforts related to the metrology program.
Assist in the review and modification of facility/equipment related PMs on an ongoing basis through participation in Reliability teams and initiatives. On-going evaluation of instrumentation spare parts inventory. Assist in the long-range planning of facility equipment replacement and upgrades. Assist in the development and maintenance of the annual departmental budget.
Oversee the Metrology Department by assuring calibration processes are in a state of compliance. Assure all calibration procedures are logical and requirements link to the instrumentation operational requirements and accuracies.
Evaluate existing and new instrument calibration work orders to determine accuracy for the instrument's capability and intended use in the field.
Provide day to day direction of three (3) Metrology Technicians and work with internal customers to prioritize/schedule work orders. Manage Calibration On-Time Performance. Process Calibration due date extensions, when necessary. Provide support of a 24/7 Manufacturing operation with "on call" support.
Perform hands on instrument calibrations as needed to supplement the existing Metrology Technician work load.
Review completed calibration PMs to ensure that work was completed accurately, and results are within stated tolerance limits.
Assume leadership role in NCR's related to Metrology processes. Lead investigations and implement corrective actions identified as applicable.
Assist Maintenance Management in the review of the site preventive maintenance procedures for thoroughness and change as needed to reflect activities required to maintain assets in top operational condition. Lead all Metrology activities and internal/external Calibration resources during site shutdowns.
Maintain GMP, ISO and SOP training compliance. Abide by PPE and good housekeeping procedures. Support WISE OWLS initiatives. All other duties as assigned.
Overall responsibility of the Metrology department, direct supervision of (3) Metrology Technicians, and all day-to-day activities.
Four-year degree in an Engineering field or another technical related field or equivalent experience. Electrical Engineering or Electronics related degree preferred.
Extensive knowledge of calibration procedures for pharmaceutical related instrumentation. Knowledge of utility systems such as Air Handler Units, HEPA filter leak testing, compounding vessels, steam piping, sterilizers, autoclaves, electronic instrumentation and water systems required. Exceptional verbal and written communication skills required. Must have demonstrated leadership qualities.
Logical approach to problem solving. Good organizational skills, able to work quickly and under pressure. Good verbal and written communication skills. Must be detailed and safety oriented and quality conscious.
Project Management and leadership abilities. Computer skills with Microsoft Office, Maximo, and Blue Mountain Regulatory Asset Manager a plus, and various tools.
Pharmaceutical or food industry experience a plus.