Bio Process Operations Technician
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 BioProcess Operations Technician is responsible for providing shop floor operations and environmental monitoring support to the aseptic manufacturing areas of the manufacturing facility at the Wilson, NC Site. Responsibilities will include direct operational support for manufacturing activities including CIP / SIP, aseptic primary filling, inspection, packaging, and other operations activities as needed. This position will also be responsible for performing various supporting roles within the facility such as executing routine room and equipment disinfection and managing the movement of gowning, disinfectants, and materials to support the manufacturing areas. In addition to supporting operations activities, the role will be responsible for ensuring that EHS and GMP compliance is maintained within their area of assignment.
This position will be an individual contributor and member of the Operations team within the integrated process team (IPT).
This position is for 2nd Shift Wilson Rota POD IPT. Hours are Monday - Friday 2pm to 10:30pm.
Primary Responsibilities
_Delivery_
- Execute manufacturing operations, environmental monitoring, and facility disinfection within the Pod vaccine manufacturing facility
- Set up and operate vaccines formulation, CIP/SIP, aseptic primary filling, packaging, inspection and additional support equipment within qualified parameters
- Identify potential equipment problems and partner with other Vaccines Maintenance Technicians to ensure appropriate resolution
- Demonstrate ability to troubleshoot process, electronic systems and equipment for routine and basic problems
- Perform other duties as requested by the Operations coach
_Compliance_
- Responsible for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)
- Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)
- Complete documentation in batch records, electronic logs, or other systems in accordance with site procedure
- Maintain good housekeeping and 5S in assigned work area
- Adhere to the highest level of data integrity while performing duties
- Identify potential quality or safety issues. Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation
_Cost_
- Ensure that startup activities for area of assignment are executed such that project deliverables and timelines are met
- Closely monitor team / process performance and improve reliability through problem solving and continuous improvement
- Set up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards
- Identify and help implement continuous improvement and productivity enhancements within the IPT
_Team_
- Partner with Technicians and cross-functional support groups for assigned area to maintain an inclusive and positive work environment
- Demonstrate a high degree of maturity and personal integrity. Strictly adhere to all site policies on personal conduct and attendance
- Train, develop, and mentor other team members to share experience and best practices
- Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team
- Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving
- Routinely demonstrates leadership and conflict-resolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360° performance review
Education Minimum Requirement
- High School diploma or equivalent and previous experience operating, maintaining, troubleshooting, and/or repairing industrial equipment is preferred | Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates such as Bioworks preferred
Required Experience and Skills
- Three or more years in a GMP manufacturing facility (aseptic GMP environment strongly preferred)
- Ability to work independently as Team member
- Interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment
- Leadership ability, peer training experience, and/or productivity improvement activities strongly preferred.
- Ability to gown and work in an aseptic environment
- Ability to work with computerized and automated systems
- Willing to work irregular hours to support multi-shift operation on an as needed basis
Preferred Experience and Skills
- Aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations
- Working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
- Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
- SAP/MES/electronic log book basic knowledge from a production execution perspective
- Ability and drive to work autonomously and help organize priorities and work with other team members
- Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team
- Ability to support technical writing of documents such as standard operating procedures (SOPs)
