Metrology Specialist

Role Summary

Metrology Specialist based in Raleigh, NC. Reports to the Plant Maintenance Supervisor. Responsible for leading advanced calibration activities, maintaining metrology standards, and supporting planning, quality, and continuous improvement of metrology systems in a pharmaceutical manufacturing environment.

Responsibilities

• Leads, conducts & participates in systematic problem solving. Supports cross-functional investigations in all customer areas
• Evaluates measuring equipment performance & effectiveness of tasks & frequencies. Responds to potential issues
• Provides coaching & support to metrology technicians & process owners for measuring equipment.
• Accurately performs complex mathematical formulas relating to calibrations
• Writes procedures & SOPs for performing calibrations & repairs on measuring equipment in the production & utility areas
• Designs/Redesigns/Evaluates/Optimizes metrology systems & equipment
• Supports and/or executes engineering studies & qualification testing for measuring equipment
• Performs complex calibrations in the areas of temperature, pressure, conductivity, humidity, pH, TOC, flow, mass & frequency
• Maintains critical metrology standards, equipment & tools
• Attains & maintains required site operation & safety certifications. Maintains training qualifications on time
• Supports management & planning department in planning for completion of calibrations
• Reviews & approves calibration documentation for accuracy & completeness
• Identifies & handles deviations & failure investigations per proper procedures. Supports process owners & Quality personnel in investigations
• Organizes & coordinates with outside vendors for calibrations that must be sent out, follows-up & reports on progress of these items
• Develops work packages & creates plans to support metrology technicians to include required documents, parts & specialized tools or equipment
• Leads calibration activities as scheduled, supported by the Supervisor. Prioritizes & leads unplanned calibration activities based on business need
• Process confirms calibration activities are performed per standards
• Supports Metrology Specialists in developing new or improved calibration methods & procedures
• Ensures team members are trained to the standard.
• Other Accountabilities
• Addresses safety, quality, staffing, or personnel issues & escalates to Supervisor if necessary
• Owns KPI’s or contributes to KPI reporting
• Follow established SOPs and documentation procedures
• Perform additional duties and responsibilities as assigned

Qualifications

• High School Diploma/GED required
• Minimum five (5) years of relevant metrology/calibration experience in pharmaceutical or other highly regulated industries
• Proficiency in metrology, calibration, instrumentation and controls, electro-mechanical systems, and electronics
• Experience calibrating process and utility instrumentation and calibration field standards
• Experience using electronic calibration management systems (e.g., Calman, SAP, Blue Mountain RAM, ProCal, MAXIMO)
• Ability to read and apply schematics, wiring diagrams, and technical documentation
• Strong computer literacy, including Microsoft Office applications
• High level of organization in task management and logical planning
• Systematic approach to problem-solving and troubleshooting
• Ability to document issues thoroughly and drive rapid resolution
• Strong verbal and written communication skills, with knowledge of cGMPs, and the ability to follow good documentation practices

Skills

• Verbal and written communication skills
• Knowledge of cGMPs and good documentation practices
• Problem-solving and troubleshooting abilities
• Strong documentation and record-keeping
• Proficiency with standard office software

Education

• High School Diploma or GED (required)

Additional Requirements

• Ability to frequently lift and move objects weighing up to 50 pounds or more
• Capability to stand for long periods and perform physical tasks like bending and twisting
• Ability to ascend and descend ladders
• Work both indoors and outdoors, in various weather conditions