About The Position

This is an onsite technical position responsible for instrument calibrations and operation to keep facility instrumentation and equipment—including process, utility, and general equipment—in compliance with cGMPs. The role performs preventive maintenance and repairs, monitors and troubleshoots plant utilities, supports contractors, and manages small projects. The position is part of a multi-shift operation and may be assigned to a regular off shift and/or weekend schedule.

Requirements

  • High school diploma or GED required.
  • Comfort using Microsoft Office applications, including Word and Excel.
  • Basic knowledge of computerized maintenance management systems (CMMS).
  • Basic knowledge of electrical systems and electronics.
  • Basic understanding of pneumatic, electrical, and mechanical control systems, including PID controllers, smart devices, programmers/communicators, and multimeters.
  • Basic understanding of engineering principles as applied to facility and production equipment.
  • Basic knowledge of instrumentation field wiring and connections to PLCs, including loop-powered and self-powered instruments, RTDs, and thermocouples.
  • Detail oriented, with hands-on ability to isolate problems and identify root causes.
  • Ability to focus on problems systematically and troubleshoot systems and instruments.
  • Ability to clearly describe technical issues and neatly document work performed.
  • Ability to follow preventive maintenance procedures that define required tasks.
  • Working knowledge of OSHA safe work practices.
  • Ability to read P&IDs, electrical drawings, and blueprints.
  • Ability to work independently with some supervision and to work effectively as a team member.
  • Good organizational, interpersonal, and oral and written communication skills.
  • Comfort working in a production environment with multiple priorities and a performance culture emphasizing responsiveness.
  • Ability to understand and meet customer timelines, juggle multiple tasks with supervisory guidance, and work overtime as needed.
  • Flexibility to work multiple shifts and off hours during shutdowns, including possible regular off-shift and/or weekend assignments.
  • Ability to read Standard English documents such as standard operating procedures, maintenance schedules, and operating manuals.
  • Ability to wear cleanroom and protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
  • Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

  • Trade school education or certification in a technical discipline.
  • At least 1 year of maintenance experience in a manufacturing or laboratory environment.
  • Experience in a pharmaceutical or similar regulated industry.
  • Some experience troubleshooting mechanical and electrical control problems, including Allen-Bradley or Siemens PLCs.
  • Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance.

Responsibilities

  • Perform preventive maintenance by following written procedures and completing work orders and logbooks in accordance with company policies, procedures, cGMP, health, and safety requirements.
  • Perform preventive maintenance on plant equipment and coordinate access around customer needs.
  • Respond to customer requests and alarm conditions; assess instrument failures, identify problems, and restore equipment to operation.
  • Document repair activities and support Quality Assurance investigations of failures and breakdowns.
  • Monitor site and clean utility operating parameters, respond to out-of-range conditions or trends, and troubleshoot issues.
  • Support contractors working in the building, ensure they follow company safety and cGMP standards, and oversee the technical quality of their work.
  • Manage small projects valued at less than $10,000 through completion.
  • Perform other tasks and duties as assigned by management.
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