Associate Tech, Operations Night/day Shift

Upstream Fermentation Manufacturing Process Support

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company's lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Media Preparation, Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning.

Responsibilities may include but are not limited to:

• Support operations production through start-up and commissioning and qualification through licensure and ramp up.
• Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for production.
• Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product.
• Maintains, inventories, and transports all required equipment, materials, supplies and products. Ensures shipment criteria and timely availability and delivery.
• Performs general maintenance and assists or ability in troubleshooting of equipment independently.
• Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans, and prepares equipment used in production.
• Performs sampling/in-process testing supporting the manufacturing and validation process for current process.
• Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
• Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety, or environmental training/initiatives as required.
• Self-motivated to maintain own training status and ability to train others.
• Participate in document design activities working alongside operations team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.

Education Minimum Requirement:

• High School Diploma/GED or higher

Minimum Required Experience and Skills:

• 0 to 1 year of manufacturing work experience or Associates Degree in science or related field in lieu of experience.
• Demonstrated written and verbal communications skills
• Must be willing and able to lift 50 lbs and work on elevated platforms.
• Must be willing to work 12-hour shifts:
• If day position hours will be 6am-6pm.
• If night position hours will be 6pm-6am.
• Must be willing to work a 2-2-3 schedule (2 days on, 2 days off, 3 days on) which includes every other weekend.

Preferred Experience and Skills:

• Bioworks Certificate in addition to minimum required experience and skills.
• Experience training others through hands-on training.
• Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements.
• Demonstrated ability to work both independently and as a part of a team.

Required Skills: Accountability, Cleanroom Gowning, Computer Literacy, Equipment Set Up, Good Manufacturing Practices (GMP), Manufacturing Processes, Operations Management, Operations Support, Process Improvements, Process Manufacturing, Process Monitoring, Production Support, Quality Management, Safety Procedures, Shift Work, Time Management, Written Communication.

Preferred Skills:

Accountability, Cleanroom Gowning, Computer Literacy, Equipment Set Up, Good Manufacturing Practices (GMP), Manufacturing Processes, Operations Management, Operations Support, Process Improvements, Process Manufacturing, Process Monitoring, Production Support, Quality Management, Safety Procedures, Shift Work, Time Management, Written Communication.