Associate Technician, Operations

Merck•Wilson, NC

6d•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 vaccine manufacturing, including primary filling, inspection, packaging, and CIP/SIP. The role also performs routine room and equipment disinfection and manages the movement of gowning, disinfectants, and materials. The technician is accountable for maintaining EHS and GMP compliance in the assigned area. The position executes manufacturing operations and facility disinfection, sets up and operates equipment within qualified parameters, and identifies equipment or process problems for resolution with maintenance technicians. The technician follows safety procedures, cGMPs, and SOPs; completes electronic batch records, logs, and related documentation; maintains housekeeping and data integrity; and escalates potential quality or safety issues while assisting with investigations and CAPA implementation. The role supports area start-up deliverables, reliable equipment operation, continuous improvement, and productivity enhancements. It works with technicians and cross-functional groups, shares knowledge and best practices, and may train and mentor team members. The position reports directly to the Manager, Maintenance & Operations, with no direct reports. The scheduled second shift is 2:00 p.m. to 10:30 p.m.; irregular hours may be required 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 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.
Ability and willingness to wear a respirator for short periods as required and comply with respiratory protection program requirements.
Ability to work the scheduled second shift, 2:00 p.m. to 10:30 p.m.

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, 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 in 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.
Leadership ability, peer-training experience, and/or productivity-improvement experience.
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 other equipment operations within qualified parameters.
Identify potential equipment problems and work 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.
Follow safety procedures, including hazardous work permitting, LOTO, and HECPs, and use applicable safety equipment and PPE.
Perform operations in accordance with current cGMPs and SOPs.
Complete electronic batch records, electronic logs, and other documentation according to site procedures.
Maintain good housekeeping and 5S in the assigned work area and uphold data integrity.
Identify and escalate potential quality or safety issues; assist with investigations, root-cause determination, and CAPA implementation.
Execute start-up activities to meet area deliverables and timelines.
Monitor team and process performance and improve reliability through problem-solving and continuous improvement.
Set up and operate equipment according to 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 for the assigned area.
Train, develop, and mentor team members by sharing experience and best practices.
Build and share operations knowledge and skills in the assigned area.
Support a continuous-improvement/MPS culture focused on standard work, visible problems, waste reduction, lower process variability, and problem-solving.
Demonstrate leadership and conflict-resolution skills and provide and receive constructive feedback.