Technician, Operations

Job Description

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. 

Education Minimum Requirement: 

• High School Diploma or equivalent is required for this position. Prefer Bachelor’s degree in Life Science or Engineering or Associate’s degree in Life Science or Engineering with at least 2 years relevant experience 

Required Experience and Skills:  

• Must be willing to work 12-hour night shift (6:00PM to 06:30AM) on a rotating 2-2-3 schedule.  Note that 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). 

Preferred Experience and Skills: 

• 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 

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