Manufacturing Engineer II

Description: 

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.

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