Sets up equipment for routine processes. Operates complex equipment and monitors manufacturing processes. Conversant with overall functionality of departmental processes. Communicates all operational events and issues with appropriate individuals. Identifies opportunities for improvement throughout the operations and assists in the implementation of changes both in physical operations and written documents. Operates all certified jobs and maintains operating conditions within the desired range with minimal supervision. Sets up equipment to accommodate minor processing changes. Is knowledgeable on work processes to assist with identifying and implementing work improvements.

Responsibilities

• Performs functions associated with cGMP manufacturing operations, including aseptic techniques within the biologics production facility.
• Working with mammalian cell cultures in a cleanroom environment.
• Demonstrates compliance to local and industry quality and safety standards.
• Proficient in either manual or controlled process equipment.
• Has knowledge of equipment and manufacturing process and can operate with minimal help of the certified and qualified trainer. Comprehends and applies all required technical, regulatory, and safety training.
• Ability to troubleshoot problem situations with minimal assistance.
• Under minimal supervision makes timely decision to accomplish department goals. Recommends improved manufacturing and departmental processes, and takes ownership of tasks
• Listens actively to acquire information and understand work procedures. Participates in the sharing of information to promote overall efficiency of production. Attends and actively participates in meetings
• Works to resolve conflict in professional and constructive manner with individuals inside and outside operating environment.
• Hours required for work are 4 x 10 hour shifts.