Senior Metrology Technician

Position Summary

The Senior Metrology Technician is responsible for maintaining a safe work environment and for calibration, maintenance, troubleshooting, and performing repairs on the process instrumentation and manufacturing equipment systems. This position will overhaul and perform corrective and preventive maintenance on plant equipment, filtration systems, pumps, air handling units, sterilization, filling equipment, plant and critical utility equipment electrical controls and instrumentation to include, pressure/level/temperature/pH indicators and transmitters, electrical distribution, variable frequency drives, electric motors, and electrical control systems. This position will prepare calibration reports and detailed documentation for completed work orders.

Essential Functions

• Perform calibration, preventive maintenance and repair of critical and analytical plant equipment on a regular basis, including manufacturing, filling, sterilization equipment, and electrical control systems in both cGMP and non-cGMP areas.
• Repair and or replace mechanical, electrical and controls components of manufacturing, sterilization, and packaging equipment as assigned.
• Install new equipment; perform modifications on equipment to make it compatible with existing equipment or to enhance its functions,
• Provides advanced technical and electronic equipment repair work.
• Safely use hand tools, power tools, and equipment on a daily basis to accomplish tasks.
• Use common laboratory measuring, calibrating, and test equipment.
• Verify the accuracy of gauges and measuring instruments such as dial indicators, fixed gauges, height gauges, and electrical and functional gauges.
• Troubleshoot, and repair critical equipment including plant equipment, filtration systems, pumps, sterilization, filling packaging equipment, and electrical controls such as indicators, electrical distribution, variable frequency drives, electric motors and electrical control systems.
• Collaborate with facility team to support data management of instrumentation and equipment via equipment management / work order system.
• Order spare parts for critical equipment and materials needed for daily operations.
• Provide guidance regarding equipment operation.
• Assist in preparing and maintaining accurate records, reports, and work instructions.
• Conduct daily facility walk-thru inspection, identifying and resolving issues immediately
• Maintain cleanliness and safety of the shop and facilities.
• Oversee services performed onsite by maintenance subcontractors.
• Support engineering projects including but not limited to: equipment installation, commissioning, and validation process.
• Ensure compliance with all applicable regulatory agencies including FDA, CA FDB, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
• Follow and comply with EPA, OSHA, and NFPA regulations and with SOPs and cGMP policies.
• Support management in audits.
• Provide measurement data for MDT.
• Manage and schedule shutdown activities from start to finish.
• Manage and schedule work for calibration and maintenance for daily operation.
• Write an investigation report for any failed calibration, especially calibration standards, through Quality Management System.
• Replace and repair electronic and pneumatic sub-assemblies, integrated circuits, relays, and calibrate, maintain, troubleshoot, and perform repairs on the electrical and instrumentation systems; design and/or improve new or existing control systems for autoclaves, bioreactors, water systems, boilers, chillers, and HVAC systems.
• Plan and schedule corrective maintenance, preventive maintenance, and calibration work orders on analytical instruments and other laboratory instruments such as pH meters, Torque tester, refrigerators, freezer, Incubators, water baths, conductivity meters, mixers, etc.
• Additional responsibilities may include manufacturing supports systems and equipment and office building equipment /systems (i.e. monitor the building management system “BMS”).
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs.

Education & Experience

• High School diploma or equivalent with 9+ years of relevant GMP facility experience in the biotech/pharma industry required; or
• Associate’s Degree (A.A.) or equivalent certifications from a technical school with 7+ years of relevant GMP facility experience in the biotech/pharma industry required; or
• Bachelor's degree with 5+ years of relevant GMP facility experience in the biotech/pharma industry required
• ASQ Certification preferred but not required
• Experience with and working knowledge of Computerized Maintenance Management Systems (CMMS) required
• Experience with and working knowledge of facilities equipment and preventive maintenance programs required
• In-depth, working knowledge of Metrology and calibration programs required
• Critical Utility Systems (WFI, PUW etc.) required

Knowledge, Skills, & Abilities

• Self-starter with the ability to work with minimum supervision
• Ability to work in a fast-paced environment and maintain a high level of customer service
• Knowledge of and ability to use all hand tools and sets up and uses standard tools
• Excellent Instrumentation and mechanical skills and knowledge of maintenance principles.
• Ability to perform hands-on execution of maintenance of process equipment, utility equipment, and facilities.
• Understanding of the advanced process and control theory of a critical or major system.
• Able to work independently and make sound judgments regarding safety, work methods and tools
• Ability to read wiring diagrams, blueprints, and P&ID drawings
• Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems, clean rooms, automated pharmaceutical processing, and plant equipment.
• Able to understand and perform analog, digital, frequency, and time calibration of electronic systems and components
• Excellent written and verbal communication skills to effectively convey information in face-to-face and in group settings
• Excellent teamwork and cooperation skills.
• Ability to understand and comprehend oral and written instructions
• Ability to multi-task and work independently.
• Ability to perform Standard Operational Procedures (SOP) job plans.
• Proficient at understanding and writing reports and work instructions.
• Ability to exercise good judgment.
• Great follow-through.
• Positive attitude at all times.

Working Environment / Physical Environment

• This position is onsite.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Available to work off hours (weekends, holidays, after hours) to support company objectives
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position
• Must be able to lift frequently lift up to 35 pounds and occasionally lift/move 50 pounds
• Up to 25% travel may be required