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GMP Production Technician

4 months ago

Xenia, United States Cambridge Isotope Laboratories Full time

Cambridge Isotope Separations (CIS) has an outstanding opportunity for a GMP Production Technician based onsite in our Xenia, OH location. CIS is the world leader in the separation of 13C and 18O and is a subsidiary of Cambridge Isotope Laboratories (CIL) in Massachusetts, the world’s leading producer of stable isotopes and stable isotope-labeled compounds. CIL separates both 13C and 18O at its Xenia, Ohio, facility and has the world’s largest production capacity for both 13C and 18O. CIL also has the only large capacity nongovernmental D2O (Deuterium Oxide) enrichment columns in the world located at its CIS facility.

Our GMP Production Technicians work in a team-based environment and are responsible for safety, production, maintenance, and product quality. They are expected to understand and use automated control systems, production machinery, and laboratory equipment. Ability to work unsupervised and a willingness to succeed is required. 

Responsibilities

Work on the GMP production process for 13C Urea for Medical Diagnostics Disassemble, clean and reassemble production equipment to prepare for processing Consistently conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meet specified parameters following strict GMP procedures Operate process equipment to create product that meets predetermined specifications Transfer processed materials through production equipment to include mixers, vacuum pumps, filtration equipment, etc. Package finished product and transfer to warehouse Adhere to all cGMP guidelines Follow all documentation procedures assuring that paperwork is in accordance with all regulatory standards Committed to meeting customer demand Additional responsibilities as required

Requirements

High school diploma or GED from an accredited institution Disciplined execution of work instructions, excellent organizational skills and strong interpersonal communication capabilities Two years of chemical/pharmaceutical production plant experience is preferred but not required GMP experience is preferred Ability to move/lift materials or equipment as needed up to 50 lbs

Benefits

CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.