Position: cGMP CleanerLocation: Frederick, MDDuration: 12 MonthsJob Type: Temporary Assignment Work Type: OnsiteShift Timing: Monday to Friday From 7:30am to 4:00pm Pay Rate: $25.00 - $28.00/HrOverview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.Job Description:GMP cleaning team cGMP Cleaner Client is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs. We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of Client’s brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.ResponsibilitiesPerforms sanitary cleaning activities as defined by established operating procedures and as directed by Manager/SupervisorPerforms sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning roomsMaintains accurate and complete recordsAttends and completes all training required by Company SOPs, procedures and policiesMaintains accurate and complete inventory of cleaning supplies ensuring supplies are never depletedReviews and provides signatory signoff of documentationProvides accurate and complete assistance to other Departments as neededWorks in a safe and effective manner in accordance with all company, state and federal rules and regulationsPerform any other tasks/duties as assigned by managementEmbrace the QUALITY cultureBasic Requirements:AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience Physical Environment and Physical Requirements:Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)Ability to wear a respirator during use of certain cleaning chemicalsPerform operations within an ISO Class clean roomsEmployee must be able to occasionally lift and/or move up to 40 poundsMust be able to squat, bend, kneel, and or reach for 80% of a shiftMust be able to stand, walk, and/or move about for 80% of a shift Preferred Qualifications:Clean Room sanitization experience or cGMP operational experience a plus Task break down (by %): 75% cleaning 15% documentation 10% other duties as assignedTekWissen® Group is an equal opportunity employer supporting workforce diversity.
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Position: cGMP CleanerLocation: Frederick, MDDuration: 12 MonthsJob Type: Temporary Assignment Work Type: OnsiteShift Timing: Monday to Friday From 7:30am to 4:00pm Pay Rate: $25.00 - $28.00/HrOverview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.Job Description:GMP cleaning team cGMP Cleaner Client is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs. We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of Client’s brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.ResponsibilitiesPerforms sanitary cleaning activities as defined by established operating procedures and as directed by Manager/SupervisorPerforms sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning roomsMaintains accurate and complete recordsAttends and completes all training required by Company SOPs, procedures and policiesMaintains accurate and complete inventory of cleaning supplies ensuring supplies are never depletedReviews and provides signatory signoff of documentationProvides accurate and complete assistance to other Departments as neededWorks in a safe and effective manner in accordance with all company, state and federal rules and regulationsPerform any other tasks/duties as assigned by managementEmbrace the QUALITY cultureBasic Requirements:AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience Physical Environment and Physical Requirements:Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)Ability to wear a respirator during use of certain cleaning chemicalsPerform operations within an ISO Class clean roomsEmployee must be able to occasionally lift and/or move up to 40 poundsMust be able to squat, bend, kneel, and or reach for 80% of a shiftMust be able to stand, walk, and/or move about for 80% of a shift Preferred Qualifications:Clean Room sanitization experience or cGMP operational experience a plus Task break down (by %): 75% cleaning 15% documentation 10% other duties as assignedTekWissen® Group is an equal opportunity employer supporting workforce diversity.
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