Associate Technician, Maintenance

MSD•Wilson, NC

1d•Onsite

About The Position

The Bio Process Maintenance Associate Technician is an individual contributor on the Maintenance & Operations team supporting 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 aseptic manufacturing operations. The role contributes to product quality, cost-effective operations, on-time delivery, and continuous improvement. Shop-floor activities include aseptic primary filling, inspection, packaging, CIP/SIP, and room and equipment disinfection. The technician sets up, changes over, adjusts, operates, inspects, troubleshoots, repairs, cleans, lubricates, and maintains production and process equipment. Duties include executing corrective and preventive maintenance, making routine adjustments, assisting with equipment overhauls and calibration, identifying equipment failure causes, and documenting maintenance and manufacturing information in required systems. The role also includes helping resolve potential equipment problems in partnership with Vaccines Maintenance Technicians and supporting start-up, reliability, and productivity improvements. The technician performs work in accordance with current SOPs, competency-based training, cGMPs, site procedures, and safety requirements. Responsibilities include maintaining accurate GMP documentation and data integrity, using applicable PPE and safety procedures, maintaining housekeeping and 5S, escalating quality or safety concerns, and assisting with investigations, root-cause analysis, and CAPA implementation. The technician collaborates across teams and shifts, shares knowledge, and may train or mentor other team members. This is an 8-hour first-shift position, scheduled 6:00 a.m. to 2:30 p.m., with willingness to work irregular hours as needed to support multi-shift operations. A high school diploma or equivalent and at least one year of experience in a GMP manufacturing facility, including maintenance experience, are required. Aseptic GMP experience is strongly preferred.

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 in an inclusive, feedback-oriented, empowered culture.
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 to follow safety procedures and use applicable safety equipment and PPE.
Ability to maintain accurate GMP documentation and adhere to data-integrity requirements.
Ability to troubleshoot equipment and interpret technical information, drawings, diagrams, and schematics.
Demonstrated maturity, personal integrity, and adherence to site conduct and attendance policies.

Nice To Haves

Associate degree in Business, Science, or a technology-based field, and/or bio-pharma-focused certificates such as BioWorks.
Experience troubleshooting maintenance issues and handling preventive and corrective work orders.
Experience with aseptic filling equipment, 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 they apply to the vaccine or pharmaceutical industry.
Experience with Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies.
Basic EAM, SAP, MES, and 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

Set up, change over, and adjust production and process equipment according to current SOPs and competency-based training modules.
Perform corrective and preventive maintenance on manufacturing equipment.
Conduct equipment test runs and make basic adjustments to timing, alignment, machine height, settings, and clearances.
Disassemble and inspect equipment to identify causes of improper operation; repair and reassemble equipment using replacement or repaired parts.
Clean and lubricate machinery and perform routine maintenance to support efficient equipment operation.
Perform minor equipment 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.
Prepare accurate GMP-compliant documentation and complete records in EAM, electronic batch records, electronic logs, and other required systems.
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 to resolve them.
Troubleshoot routine and basic process, electronic-system, and equipment problems.
Perform assigned work safely, following safety procedures such as hazardous-work permitting, LOTO, and HECPs, and use applicable PPE.
Perform maintenance and operations in accordance with cGMPs, SOPs, site procedures, and data-integrity requirements.
Maintain good housekeeping and 5S in the assigned work area.
Identify and escalate potential quality or safety issues and assist with investigations, root-cause determination, and CAPA implementation.
Support start-up activities and meet area deliverables and timelines.
Monitor team and process performance, solve problems, and improve equipment reliability and productivity.
Identify and help implement continuous-improvement and productivity enhancements within the IPT team.
Partner with technicians, operations personnel, and cross-functional groups for the assigned area.
Train, develop, and mentor team members; provide specialized training to Manufacturing Division employees when required.
Pursue and share operations knowledge and skills, and contribute to standard work, waste reduction, process-variability reduction, and problem solving.
Demonstrate leadership, conflict-resolution skills, and willingness to provide and receive constructive feedback.
Perform other duties as requested by the Operations Coach.