Assoc. Tech, Operations - Production Support and Media

Job Description

Position Description

This position is currently designated Mon-Fri, dayshift, and will work the 06:00am – 2:30pm.

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 traceability 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 (e.g. parts washers and autoclaves).

• 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:

• BioWorks Certificate (working in an FDA regulated industry).

• Previous experience in a GMP environment is preferred.

• 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, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator

• Demonstrated verbal and written communication skills

• Must be able to demonstrate basic computer literacy (internet browsers, e-mail, word processing)

• Successful completion of TB titer and Chest X-ray are required.

The following experience is an advantage for an Associate Technician supporting our Production Support and Media operations:

Preferred Experience and Skills (General):

• Previous experience working in Grade C/D environment

• Experience working with parts washers, autoclaves, and sterile components

• Experience with media formulation or weigh and dispense of raw materials

• Experience in the use of Electronic Batch Records

• Experience performing Environmental Monitoring and Sampling

• Experience cleaning in Grade C/D environment

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