Technician, Operations

MSD•Durham, NC

1d•$57,900 - $91,200•Onsite

About The Position

This is a night shift position, 12.5 hour (6:00PM – 6:30 AM) rotation (2-2-3). The Vaccine Manufacturing Facility Production Associate is an excellent opportunity for experienced individuals that are interested in working in vaccine production and manufacturing operations. The individual in this position will support the vaccine manufacturing process through hands on processing activities. Key responsibilities for the Production Associate include the execution of aseptic processing requirements, adherence to Good Manufacturing Practices, and working in a self-directed team environment to accomplish shift and departmental goals. Responsibilities include, but are not limited to: Works collaboratively with all operations and support personnel, performing manual and automated processing of vaccine manufacturing equipment, performing general troubleshooting tasks, and supporting functions necessary for the production of vaccines. Executes all documentation and clerical functions necessary for proper accountability and trace-ability of product. Maintains, inventories, and transports all required processing equipment, materials, supplies and products needed to support manufacturing. Operates various computer-controlled process support/process equipment (i.e. washer, autoclave, vial filler, lyophilizer, capping/inspect machines, etc.). Assists in troubleshooting of equipment. Performs housekeeping in all work areas. Executes facility sanitization and decontamination according to approved procedures. Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate and escalates to appropriate personnel. Maintains, cleans and prepares equipment used in vaccine manufacturing process. Schedules and performs environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required. Attends and actively participates in safety & housekeeping, walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. Serves on safety, quality and other committees as required.

Requirements

Must be willing to work 12-hour night shift (6:00PM to 06:30AM) on a rotating 2-2-3 schedule
This schedule does include working alternating weekends and holidays
Must be able to successfully pass Aseptic gowning qualification
Aseptic gowning requires that all skin and hair be covered through wearing the following: Beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots
Must be willing and able to lift 50 lbs
Must be willing to work various shifts
Must be able to demonstrate basic computer literacy (internet browsers, e-mail, word processing)

Nice To Haves

Bachelor’s degree in Life Science or Engineering
Associate’s degree in Life Science or Engineering
BioWorks Certificate (working in an FDA regulated industry)
Experience utilizing System Applications and Products in a manufacturing setting
Experience in the use of Electronic Batch Records
Experience performing Environmental Monitoring and Sampling

Responsibilities

Works collaboratively with all operations and support personnel
Performing manual and automated processing of vaccine manufacturing equipment
Performing general troubleshooting tasks
Supporting functions necessary for the production of vaccines
Executes all documentation and clerical functions necessary for proper accountability and trace-ability of product
Maintains, inventories, and transports all required processing equipment, materials, supplies and products needed to support manufacturing
Operates various computer-controlled process support/process equipment (i.e. washer, autoclave, vial filler, lyophilizer, capping/inspect machines, etc.)
Assists in troubleshooting of equipment
Performs housekeeping in all work areas
Executes facility sanitization and decontamination according to approved procedures
Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate and escalates to appropriate personnel
Maintains, cleans and prepares equipment used in vaccine manufacturing process
Schedules and performs environmental monitoring during processing and records results in the computerized database system
Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required
Attends and actively participates in safety & housekeeping, walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required
Serves on safety, quality and other committees as required