JOB TITLE/TYPE: CLEANROOM OPERATOR - BIOMANUFACTURING
Function: Manufacturing Family: Bridge Manufacturing Services Band: Other Salary
• The Biomanufacturing Cleanroom Operator is responsible for performing Manufacturing operations according to standard operating procedures and batch instructions.
• Responsibilities include training on cGMP manufacturing operations, operation and monitoring of cell culture and/or purification equipment, writing and reviewing cGMP documentation.
Key responsibilities / essential functions:
• Demonstrate effective written and verbal communication skills.
• Reads and follows standard operating procedures and master production records or receives verbal instructions regarding duties to be performed.
• Review completed cGMP documentation for accuracy.
• Routinely originate and revise standard operating procedures, master production records and solution preparation records.
• Assist in the set up and preparation of equipment and production runs.
• Operates Cell Culture and/or Purification production equipment in a cleanroom environment.
• Operates general manufacturing equipment to formulate buffers and Media.
• Works with team lead, engineers, supervisors, and managers to improve quality and process efficiency.
• Handle and deliver products and hazardous materials in compliance with all regulations and Company Policies.
• Actively participate in maintaining a safe work environment by completing required training, providing suggestions for improving the health and safety program and bringing unsafe acts and/or conditions to the attention of management.
• 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.
• Knowledge and understanding of document control, calibration, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements.
• Associate’s degree in Science or High School Diploma and a minimum of two years of experience in biologics manufacturing under cGMP
• Ability to communicate, receive and understand instructions regarding duties to be performed
• Demonstrated ability to detail and have quality-minded work habits
• Demonstrated ability to communicate with co-workers and leadership
• Demonstrated ability to follow instruction and standard operating procedures.
• Ability to work additional hours as needed to support production.
• Associates degree in a scientific discipline or equivalent experience
• Cell Culture experience
• Protein Purification experience
• Prior experience working in a cGMP biopharmaceutical manufacturing environment
• Experience with single-use systems is preferred
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