Associate Technician, Operations

MSD•Wilson, NC

7d•Onsite

About The Position

The Bio Process Operations Associate Technician is an individual contributor on the Maintenance & Operations team within the Vaccines integrated process team at a start-up vaccine manufacturing facility in Wilson, North Carolina. The role provides shop-floor operations support for aseptic vaccine manufacturing, including primary filling, inspection, packaging, and CIP/SIP. It also includes routine room and equipment disinfection and managing the movement of gowning, disinfectants, and materials. The technician is accountable for maintaining EHS and GMP compliance in the assigned area. The position performs and supports manufacturing operations and facility disinfection, sets up and operates equipment within qualified parameters, and identifies equipment or process issues for resolution with Maintenance Technicians. The technician follows safety procedures, cGMPs, SOPs, documentation and data-integrity requirements, and supports investigations and corrective and preventive actions. The role also contributes to startup readiness, reliable operations, continuous improvement, team training, and cross-functional collaboration. The 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 follow safety procedures and applicable PPE requirements.
Ability to maintain documentation and data integrity in a regulated manufacturing environment.

Nice To Haves

Associate 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, and similar aseptic formulation and filling operations.
Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment.
Experience in a regulated environment, such as FDA-regulated manufacturing, and basic knowledge of cGMPs as applied to the vaccine or pharmaceutical industry.
Experience in 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 initiative 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, including primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters.
Identify potential equipment problems and partner with Vaccines Maintenance Technicians to resolve them; troubleshoot routine and basic process, electronic-system, and equipment problems.
Perform other duties as requested by the Operations coach.
Perform work safely by following safety procedures, including hazardous work permitting, LOTO, and HECPs, and by using applicable safety equipment and PPE.
Execute operations in accordance with current cGMPs and SOPs.
Complete documentation in electronic batch records, electronic logs, and other systems in accordance with site procedures.
Maintain good housekeeping and 5S in the assigned work area and uphold data integrity.
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 for 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 in accordance with training and procedures to support reliable operation and minimize delays or discards.
Identify and help implement continuous-improvement and productivity enhancements within the IPT.
Partner with technicians and cross-functional groups in the assigned area.
Train, develop, and mentor team members and share knowledge and best practices.
Pursue and share operations knowledge and skills in the assigned area.
Promote a continuous-improvement/MPS culture focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.
Demonstrate leadership and conflict-resolution skills and provide and receive constructive feedback in 360-degree performance reviews.
Adhere to site policies on personal conduct and attendance.