Technician, Operations

About the Role

The Bio Process Operations Technician will be a member of the Maintenance & Operations team within the Vaccines integrated process team for a start-up vaccine manufacturing facility in Wilson, NC. This person is accountable for providing shop floor operations support to aseptic manufacturing within the vaccine manufacturing facility.

Responsibilities

• Execute manufacturing operations and facility disinfection
• Set up and perform aseptic vaccine manufacturing, including primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters
• Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution
• Demonstrate ability to troubleshoot process, electronic systems, and equipment for routine and basic problems
• Perform various roles, including executing routine room and equipment disinfection, managing the movement of gowning, disinfectants, and materials
• Ensure EHS and GMP compliance within the assigned area
• Maintain good housekeeping and 5S in the assigned work area
• Identify potential quality or safety issues, escalate as per IPT management processes, and assist in investigation, root cause determination, and CAPA implementation
• Ensure startup activities for the assigned area are executed to meet deliverables and timelines
• Monitor team/process performance and improve reliability through problem-solving and continuous improvement
• Train, develop, and mentor other team members to share experience and best practices
• Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem-solving

Requirements

• High School diploma or equivalent
• Three or more years of experience in a GMP manufacturing facility (aseptic GMP environment strongly preferred)
• Ability to gown and work in an aseptic environment
• Demonstrated ability to work with computerized and automated systems
• Willingness to work irregular hours to support multi-shift operations as needed

Qualifications

• Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates (preferred)
• Experience with aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment, and similar aseptic formulation and filling operations (preferred)
• Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment (preferred)
• Experience working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry (preferred)
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies (preferred)
• SAP / MES / electronic logbook basic knowledge from a production execution perspective (preferred)

Skills

• Calibration of Equipment
• Computer Literacy
• Continuous Process Improvement
• Data Integrity
• Equipment Maintenance
• Facility Maintenance
• GMP Compliance
• Industrial Machinery Repair
• Inventory Management
• Lean Manufacturing
• Maintenance Processes
• Manufacturing Quality Control
• Mechanical Maintenance
• Operations Support
• Packaging Equipment
• Preventive Maintenance
• Process Optimization
• Production Execution
• Production Reports
• Production Scheduling
• Shop Floor Management
• Standard Operating Procedure (SOP) Writing

Pay

The salary range for this role is $57,900 - $91,200.

Schedule

8-hours, 2nd shift: 2:00 PM - 10:30 PM

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.