Associate Technician, Maintenance

MSD•Wilson, NC

3d•$47,600 - $75,100•Onsite

About The Position

The Bio Process Maintenance Associate Technician is part of the Maintenance & Operations team within the Vaccines integrated process team at a start-up vaccine manufacturing facility in Wilson, North Carolina. Under the direction of an Operations/Maintenance Coach, the technician provides maintenance support for pharmaceutical process equipment, addresses operational maintenance problems, and supports product quality, cost, schedule, and continuous improvement goals. Alongside daily maintenance activities, the technician supports aseptic manufacturing operations, including primary filling, inspection, packaging, CIP/SIP, and room and equipment disinfection. The role requires working effectively in a team-based, empowered environment, maintaining data integrity, and applying knowledge of customers, suppliers, business processes, and the supply chain to daily work. The technician sets up, operates, troubleshoots, repairs, calibrates, and maintains manufacturing and process equipment; performs preventive and corrective maintenance; and documents work in accordance with site procedures and cGMP requirements. The role also includes safety and quality responsibilities, housekeeping, continuous improvement, cross-functional collaboration, and training and mentoring team members. This is an individual-contributor position reporting to the Manager, Maintenance & Operations.

Requirements

High school diploma or equivalent.
At least one year of experience in a GMP manufacturing facility, including maintenance experience; 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 a multi-shift operation.
Ability to work safely and follow identified safety procedures and use applicable safety equipment.
Ability to troubleshoot equipment and document work in accordance with GMP and site procedures.

Nice To Haves

Associate degree in Business, Science, or a technology-based field and/or bio-pharma-focused certificates such as Bioworks.
Experience with maintenance troubleshooting, preventive and corrective work orders, aseptic filling equipment, visual inspection systems, CIP/SIP systems, packaging equipment, and similar aseptic formulation and filling operations.
Experience operating, maintaining, troubleshooting, or repairing industrial equipment.
Experience in a regulated environment such as FDA-regulated work 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 EAM, 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

Check equipment set-up, perform changeovers, and adjust production and process equipment according to current SOPs and competency-based training modules.
Perform experimental set-ups and trials at the direction of process, project, or reliability engineers.
Set machine settings and clearances, install parts, and make adjustments during initial set-up and operations.
Execute corrective and preventive maintenance on manufacturing equipment.
Test-run equipment and make basic adjustments to timing, alignment, machine height, and other settings.
Disassemble and inspect equipment to identify causes of improper operation, repair or replace parts, and reassemble equipment.
Clean and lubricate machines and perform other maintenance needed for efficient equipment operation.
Perform minor overhauls and assist with major overhauls of manufacturing, filling, packaging, and plant engineering process equipment.
Identify root causes of equipment malfunctions and make repairs or adjustments to minimize production delays.
Assist with calibration of industrial control, measurement, and recording equipment, and prepare accurate GMP-compliant documentation of measured information.
Read and interpret technical information, drawings, diagrams, and schematics to troubleshoot and repair equipment.
Set up and perform aseptic vaccine manufacturing activities, including primary filling, inspection, packaging, CIP/SIP, and operation of additional equipment within qualified parameters.
Identify potential equipment problems and partner with Vaccines Maintenance Technicians on resolution; 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 maintenance and operations in accordance with cGMPs and SOPs.
Complete documentation in EAM, electronic batch records, electronic logs, and other systems according to site procedures.
Maintain 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.
Participate in or provide specialized training to Manufacturing Division employees as needed.
Ensure assigned-area start-up activities meet deliverables and timelines.
Monitor team and process performance, improve reliability through problem solving and continuous improvement, and help implement productivity enhancements within the IPT.
Partner with technicians, operations personnel, and cross-functional groups for the assigned area.
Train, develop, and mentor team members; pursue and share operational knowledge and skills.
Support a continuous-improvement and MPS culture focused on standard work, visibility of problems, waste reduction, process-variability reduction, and problem solving.
Demonstrate leadership and conflict-resolution skills and provide and receive constructive feedback.