Cellectis · 3 months ago
Metrology / Facilities Technician
2500 Sumner Boulevard , Raleigh, NC, 27616, US
Full-time
Onsite
Senior Level
5+ years expCellectis is a company focused on innovative solutions in the biopharmaceutical sector. The Metrology / Facilities Technician is responsible for executing and maintaining a metrology program in support of clinical and commercial manufacturing, ensuring compliance with regulatory standards.
BiopharmaBiotechnologyHealth CareMedicalOncology
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
Qualification
Required
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
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
Preferred
PLC, HVAC, and Building Monitoring System basic working knowledge a plus
Working knowledge of Word & Excel software applications
Company
Cellectis
Cellectis is a biopharmaceutical company that develops adoptive immunotherapies for cancer.
51-200 employees
H1B Sponsorship
Cellectis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$393.48MKey Investors
European Investment BankAstraZeneca
2024-12-10Post Ipo Debt· $5.27M
2023-11-01Post Ipo Equity· $140M
2023-02-07Post Ipo Equity· $24.35M
Leadership Team
A
Arthur Stril
Chief Financial Officer & Chief Business Officer
Recent News
GlobeNewswire
2026-01-09
2026-01-06
Company data provided by crunchbase