Job Description

Responsibilities:

· The Bio-manufacturing 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.

· Throughout the new product cycle to improve internal models and/or externally sourced components in terms of system performance, reliability, functionality, and serviceability

· Provide evaluation, constructive feedback and leadership in the development of internal and external engineering, manufacturing, or service documentation

· Drive cross-department process improvements focused on reducing overall product cycle time.

· Develop and execute training plans as required Provide strong individual contributions in the context of achieving team goals.

· Provide technical leadership by assisting others in troubleshooting, answering questions and seeking engineering assistance

· Train other team members through technical communications and/or presentations Lead compliance and quality activities by looking for defect trends, learning about quality issues and concessions and passing information to other technicians.

· Serve as the manufacturing expert on new product introductions by providing feedback to engineering and manufacturing personnel as new products are developed and new procedures are implemented.

· Lead EHS projects/activities designed to eliminate hazards and improve overall safety of job operations

· Fill in as a Lead Technician as required by directing the work team, making task assignments and completing daily reports

· May participate in quality control inspections of certain subassemblies and final product Comply with EHS regulations and policies