Associate Technician, Operations

MSD•Wilson, NC

5d•Onsite

About The Position

The Bio Process Operations Associate Technician is a member of the Maintenance & Operations team within the Vaccines integrated process team at a start-up vaccine manufacturing facility in Wilson, North Carolina. This individual contributor provides shop-floor operations support for aseptic manufacturing, including primary filling, inspection, packaging, and CIP/SIP. The role also performs room and equipment disinfection and manages the movement of gowning, disinfectants, and materials. The technician is responsible for maintaining EHS and GMP compliance in their assigned area, executing manufacturing and disinfection activities safely and according to procedures, and maintaining accurate electronic documentation. The position contributes to reliable equipment and process performance, startup deliverables, problem-solving, and continuous improvement. The technician also shares operational knowledge and may train, develop, and mentor other team members. The role reports directly to the Manager, Maintenance & Operations. The work schedule is second shift, 2:00 p.m. to 10:30 p.m., with willingness to work irregular hours as needed to support multi-shift operations.

Requirements

High school diploma or equivalent.
At least one year of experience in a GMP manufacturing facility; aseptic GMP experience is strongly preferred.
Ability to work independently and as a team member.
Interpersonal skills and ability to influence and assist others through inclusion, feedback, and empowerment.
Ability to gown and work in an aseptic environment.
Ability to work with computerized and automated systems.
Willingness to work irregular hours as needed to support multi-shift operations.
Willingness and ability to wear a respirator for short periods as required and comply with respiratory protection program requirements.
Ability to adhere to site policies on personal conduct and attendance.

Nice To Haves

Associate's degree in business, science, or a technology-based field, and/or biopharma-focused certificates such as Bioworks.
Experience with aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment, or similar aseptic formulation and filling operations.
Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment.
Experience in a regulated environment, such as FDA-regulated work, and basic knowledge of cGMPs as they apply to the vaccine or pharmaceutical industry.
Experience with continuous improvement, lean manufacturing, problem-solving, and/or Right First-Time methodologies.
Basic SAP, MES, or electronic logbook knowledge from a production execution perspective.
Demonstrated leadership ability, peer-training experience, and/or productivity-improvement activities.
Ability and drive to work autonomously, organize priorities, and work with other team members.
Strong communication skills within the direct team and across multiple shifts.
Ability to support technical writing of documents such as SOPs.

Responsibilities

Execute manufacturing operations and facility disinfection.
Set up and perform aseptic vaccine manufacturing activities, including primary filling, inspection, packaging, CIP/SIP, and other equipment operations within qualified parameters.
Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution.
Troubleshoot routine and basic process, electronic-system, and equipment problems.
Perform other duties as requested by the Operations coach.
Perform work safely, follow identified safety procedures—including hazardous work permitting, LOTO, and HECPs—and use applicable safety equipment and PPE.
Execute operations in accordance with current GMPs and SOPs.
Complete electronic batch records, electronic logs, and other documentation in accordance with site procedures.
Maintain good housekeeping and 5S in the assigned work area.
Maintain data integrity while performing duties.
Identify potential quality or safety issues, escalate them through IPT management processes, and assist with investigations, root-cause determination, and CAPA implementation.
Ensure startup activities in the assigned area meet deliverables and timelines.
Monitor team and process performance and improve reliability through problem-solving and continuous improvement.
Set up and operate equipment according to established training and procedures to promote reliable operation and minimize delays or discards.
Identify and help implement continuous-improvement and productivity enhancements within the IPT team.
Partner with Technicians and cross-functional groups for the assigned area.
Train, develop, and mentor team members by sharing experience and best practices.
Pursue and share operational knowledge and skills in the assigned area.
Promote continuous improvement and MPS through standard work, making problems visible, minimizing waste, reducing process variability, and problem-solving.
Demonstrate leadership and conflict-resolution ability and provide and receive constructive feedback.