NTO Manufacturing Associate

Position Overview

This is a 12 hour, rotating nighttime position in a flexible, single-use technology, large scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations. The Manufacturing Associate will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

Main Responsibilities

• Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.
• Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
• Follows verbal and written procedures in operating production and equipment and performing processing steps; accurately completes appropriate production documentation.
• Maintains cleanliness and orderliness in process area.
• Ensures production area is stocked with supplies.
• Performs batch record review, EWI (Electronic Work Instruction) revisions, and work order generation.
• Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSIT, Validation, etc.
• Utilizes manufacturing knowledge to improve process operations and affect positive change.
• Demonstrates ability to troubleshoot basic mechanical operations.
• Effectively utilizes Microsoft Office applications.
• Mentors less experienced operators.
• Fulfills the role of Team Lead in the absence of the Manufacturing Sr. Associate.
• Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and/or appropriate functional area(s).
• Performs in process analytical testing.
• Demonstrates general knowledge of automation systems (INFOR, MES, ERP, DeltaV).
• Demonstrates general knowledge and practice of aseptic techniques.

Additional Responsibilities

• Cross train manufacturing personnel
• Contributes to continual improvement of all manufacturing documentation (SOP's, EWI's, MBR's, OJT's) to ensure they are current, accurate, and clear.
• Supports plant floor continuous improvement initiatives.

Basic Qualifications

• High School diploma/GED with 3-5 years of experience in a cGXP environment, or a Bachelor's degree with 1-3 years of experience.
• Must have prior experience in cGMP manufacturing operations.

Preferred Qualifications

• Bachelor's degree with 2-4 years of experience in bulk biologics GMP manufacturing.
• Effectively uses process automation systems to operate production processes (i.e. Delta V).
• Familiarity with deviation management systems

Special Working Conditions

• Ability to lift up to 50 lbs.
• Ability to stand on average 10 hours per shift.
• Ability to gown and gain entry to manufacturing areas.
• Ability to work a twelve hour rotating shift and every other weekend, including holidays as scheduled.