Senior Metrology Technician

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.
• Provide advanced technical and electronic equipment repair work.
• Safely use hand tools, power tools, and equipment on a daily basis to accomplish tasks.
• 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.
• Avoidance of any unsafe conditions and reporting any hazards to supervisor.
• Prepare and maintain 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

• Add additional responsibilities as 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.

• 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.

• Able to understand and comprehend oral and written instructions.

• Able to multi-task and work independently.

• Able to perform Standard Operational Procedures (SOP) job plans.

• Proficient at understanding and writing reports and work instructions.

• Able 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.

• Up to 25% travel may be required.

Compensation

• The hourly base pay range for this position is below.

• The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

• $38.95 (entry-level qualifications) to $43.27 (highly experienced) per hour.

Benefits

• Medical, Dental and Vision Plan Options.

• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.