Metrology / Facilities Technician

Metrology Activities Manager

This role is responsible for the execution, accountability, and ownership of Metrology activities at the Cellectis, Raleigh, NC facility. Responsible for maintaining an audit ready metrology program in support of clinical and commercial manufacturing.

This role requires a deep understanding of metrology principles, advanced technical expertise, and strong leadership skills. This role will work cross functionally to understand end user requirements and maintain the traceability and accuracy of all instrumentation. Also provides general facilities mechanic/technician support for Facilities team.

POSITION RESPONSIBILITIES:

• Responsible for execution of all GMP instrumentation Maintenance and Calibration activities that are not directly executed by the end user via SOPs or Work Instructions.
• Perform variety of duties including calibration, troubleshooting, maintenance, and repair of instrumentation in accordance with established SOPs.
• Strict adherence to cGMPs, written procedures following good documentation practices and regulatory expectations for instrument calibrations.
• Support equipment owners in all aspects related to instrumentation (cal specs, problem solving, instrument selection, failure investigation).
• Ensure execution of calibration activities on time, to standard & with minimal impact on operations.
• Interacts with other departments during planning and process improvement activities to ensure timely completion of all operational area(s) objectives and milestones.
• Support other technicians in training, problem solving, & improvement projects.
• Drive improvements in calibration methods, standards, & specifications to meet stakeholder and site needs.
• Manage documentation change request for all calibration related SOP's and vendor calibration records ensuring accuracy and consistency.
• Flexibility to be part of an on-call rotation and ability to work nights/weekends as required to support Facility operations as a general facilities mechanic/technician.
• Partner with Metrology/Facilities Mechanics and Site Coordinator to maintain active inventory of spare parts.
• Interface with external customers and FDA during audits and inspections.
• Perform all duties in accordance with all applicable safety regulations. Monitoring overall job environmental, health and safety aspects and understand the risks and liabilities associated with various facilities maintenance and repair activities. Recognize hazard conditions, taking 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 pharmaceutical calibrations/metrology or other highly regulated industry.
• 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.
• Knowledgeable in the following systems: Instrumentation, Controls, Process Improvement Methodologies, Root Cause Analysis (RCA), Pharmaceutical Processes and Utilities.
• In-depth knowledge of metrology principles, standards, and best practices.
• Demonstrated experience in measurement instrumentation theory & method development.
• Demonstrated experience in calibrating pharmaceutical or other highly regulated instrumentation.
• Proven ability to successfully work in highly regulated commercial pharmaceutical manufacturing environment with compliance to procedurally driven activities as a requirement.
• Experience in scheduling and supervising external calibration and service vendors.
• Experience with/working knowledge of a CMMS.

TECHNICAL SKILLS REQUIREMENTS / CORE COMPETENCIES:

• Serves as a subject matter expert in metrology and metrology methodologies, providing technical guidance to cross-functional teams.
• Demonstrated leadership and team management skills and ability to work effectively in a cross-functional team environment.
• Work on routine and non-routine issues; demonstrate good judgement in resolving issues or in making recommendations.
• Able to execute daily tasks with minimal instruction and general instruction for new assignments.
• PLC, HVAC, and Building Monitoring System basic working knowledge a plus
• Working knowledge of Word & Excel software applications.