Location(s): United States; Massachusetts; Marlborough
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Role Summary: The Biomanufacturing Cleanroom Operator is responsible for current Good Manufacturing Practices (cGMP) production activities. Performing Manufacturing operations according to standard operating procedures and batch instructions. Responsibilities include training on cGMP manufacturing operations, which include but are not limited to the operation and monitoring of cell culture and/or purification equipment, media and solution preparation & writing, reviewing and revising of cGMP documentation.
Essential Responsibilities: Key Responsibilities / Essential Functions: • Demonstrates effective written and verbal communication skills. • Reads and follows standard operating procedures (SOPs) and master production records (MPRs). • Executes and properly documents cGMP Biomanufacturing activities. • Performs aseptic techniques within in a clean room environment. • Operates cGMP Biomanufacturing equipment, including; o pH/conductivity meters, single use mixing tanks (XDM’s), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC). • Strong knowledge and experience with buffer and media preparation. • Able to assist in all department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies. • Knowledge of Cell Culture and/or Protein Purification production equipment, including; o Incubators, Wave Reactors, Single Use Bioreactors (XDR) o Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration • Review completed cGMP documentation for accuracy. • Revise standard operating procedures, master production records and solution preparation records. • Works scheduled shift and other off-shift coverage as required. • Works with supervisors to improve quality and process efficiency. • Actively participate in maintaining a safe work environment by completing required training and providing suggestions for improving the health and safety program as necessary. • Complies with all EHS and Quality policies and procedures. • Maintain cleanliness of cleanroom in accordance with cGMPs and facility procedures. • Perform other duties as assigned.
Quality Specific Goals: • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. • Complete all planned Quality & Compliance training within the defined deadlines. • Identify and report any quality or compliance concerns and take immediate corrective action as required.
Qualifications/Requirements: • Associates Degree/ Biotechnology Certificate/Diploma with a minimum of two years of experience in biologics manufacturing under cGMP. • High School Diploma or equivalent with a minimum of 3 years of experience in biologics manufacturing under cGMP. • Must be available to work the Night Shift; Monday – Friday, 8:00pm – 4:30am • Demonstrates ability to work in a rapidly changing climate and reacts well to change. • Demonstrates ability to communicate, receive and understand instructions regarding duties to be performed • Demonstrates strong attention to detail and have quality-minded work habits • Demonstrates ability to communicate with co-workers and leadership • Demonstrates ability to follow instruction and standard operating procedures. • Reliable, dependable, and organized. • Able to recognize problems developing, not just occurring. • Ability to work additional hours as needed to support production.
Desired Characteristics: • Associates degree in a scientific discipline or equivalent experience • Prior experience working in a cGMP biopharmaceutical manufacturing environment • Strong Buffer and Media preparation experience • Cell Culture knowledge • Protein Purification knowledge • Experience with single-use biomanufacturing systems
Locations: United States; Massachusetts; Marlborough
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