Instrumentation and Controls Technician

POSITION SUMMARY

Instrumentation and Controls Technician is responsible for performing routine calibration, preventive maintenance and repairs to instrumentation and control systems and components of production equipment, central utilities and building management systems. Troubleshoot problems in the event of equipment failure and be able to recommend parts needed for the effective repair.

The role will be required to assist manufacturing and facilities personnel in troubleshooting and diagnostic analysis on process and utility equipment. The technician will perform troubleshooting and repair efforts to return equipment to normal operation.

POSITION RESPONSIBILITIES

• Support equipment owners in all aspects related to instrumentation and controls (specifications, problem solving, instrument selection, failure investigation) .
• Support other technicians in training, problem solving & improvement projects.
• Drive improvements in calibration and maintenance methods, standards, & specifications to fulfill customer needs.
• Responsible for execution of all GMP Maintenance and Calibration activities that are not directly executed by the end user via SOPs or Work Instructions.
• Strict adherence to cGMP's, written procedures following good documentation practices and regulatory expectations for instrument calibrations.
• Flexibility to be part of an on-call rotation and ability to work nights/weekends as required to support Facility operations.
• Interface with external customers and FDA during audits and inspections.
• Interacts with other departments during planning and process improvement activities to ensure timely completion of all operational area(s) objectives and milestones.
• Perform a variety of duties including maintenance, calibration, troubleshooting, and repair of instrumentation and equipment in accordance with established SOPs.
• Ensure execution of calibration and preventive maintenance activities on time, to standard & with minimal impact on operations.
• Manage documentation change request for all calibration and maintenance related SOP's and vendor records ensuring accuracy and consistency.
• Partner with Metrology/Facilities Mechanics and Site Coordinator to maintain active inventory of spare parts.
• Perform all duties in accordance with all applicable safety regulations. Monitor overall job environmental, health and safety aspects and understand the risks and liabilities associated with various facilities maintenance and repair activities. Must be able to recognize hazard conditions, take appropriate workplace safety measures and wear appropriate personal protective equipment to suit work environment
• Such other responsibilities and duties as the Company may from time to time assign.

EDUCATION AND EXPERIENCE

• Associates Degree in related Engineering or Science discipline or equivalent combination of education & experience.
• Minimum of five (5) years of experience in calibrations/metrology/maintenance within the pharmaceutical industry or other highly regulated industry (e.g. nuclear).
• Experience with Rockwell PLCs, VFDs.
• Experience in scheduling and interacting with external service providers.
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation.
• Demonstrated experience in control systems theory.
• Demonstrated experience in maintaining and troubleshooting pharmaceutical or other highly regulated instrumentation and equipment.

TECHNICAL SKILLS REQUIREMENTS / CORE COMPETENCIES

• Knowledgeable in the following systems: Instrumentation, Controls, Process Improvement Methodologies, Root Cause Analysis (RCA), Pharmaceutical Processes and Utilities.
• Knowledge of Building Management Systems and Fire Alarm Systems.
• Able to read schematics and P&IDs.
• Ability to work effectively in a cross-functional team environment.
• Proven ability to successfully work in highly regulated commercial pharmaceutical manufacturing environment with compliance to procedurally driven activities as a requirement.
• Working knowledge of CMMS (Maximo preferred).
• Working knowledge of isolator technology (Skan preferred).
• Working knowledge of Word & Excel software applications.