Tech, Bio Process Operations

MSD • Wilson, NC

3h • Onsite

About The Position

Bio Process Operations Technician (2nd shift) 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. Tasks will include aseptic primary filling, inspection, packaging, and CIP/SIP. This position will also perform various roles to include executing routine room and equipment disinfection as well as managing the movement of gowning, disinfectants, and materials. In addition to supporting operations activities, the role will be accountable 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. Delivery Execute manufacturing operations and facility disinfection Set up and perform aseptic vaccine manufacturing to include 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 other duties as requested by the Operations coach Compliance Accountable 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 electronic batch records, electronic logs, and 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 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 groups for assigned area 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.

Requirements

• High School diploma or equivalent
• Three or more years of experience in a GMP manufacturing facility (aseptic GMP environment strongly preferred).
• Demonstrated ability to work independently and as team member
• Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion, feedback, and empowerment
• Ability to gown and work in an aseptic environment
• Demonstrated ability to work with computerized and automated systems.
• Willing to work irregular hours to support multi-shift operation on an as needed basis

Nice To Haves

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

Responsibilities

• Execute manufacturing operations and facility disinfection
• Set up and perform aseptic vaccine manufacturing to include 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 other duties as requested by the Operations coach
• Accountable 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 electronic batch records, electronic logs, and 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.
• Ensure that startup activities for area of assignment are executed such that 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 groups for assigned area
• 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.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees