Sr. Tech, Operations

Job Description

This is a day shift position, 12.5 hour (6:00 AM - 6:30 PM) rotation (2-2-3).  

The Vaccine Manufacturing Facility Senior Production Technician is an excellent opportunity for highly trained individuals with expertise working in aseptic production and manufacturing operations. The individual in this position will support the Vaccine manufacturing process through hands on processing activities.  Key responsibilities for the Senior Production Technician 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.  The ideal candidate for this position has demonstrated the ability to manage their own work activities as well as act as a key contributor toward the success of the team through the use of their decision-making and problem-solving skills and their knowledge of aseptic manufacturing. 

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.).

• Performs process troubleshooting while maintaining production schedule

• Executes equipment setup/breakdown, operational, and equipment inspections, as required

• Assists Maintenance, Instrumentation and Automation during troubleshooting of common faults/errors

• 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.

• Serves as the subject matter expert within the processing suite and trains new team members

Education Minimum Requirement: 

• High School Diploma or equivalent

Required Experience and Skills:

• At least two (2) years GMP manufacturing/processing experience, or a Bachelor’s degree in Life Science or Engineering

• Must be willing to work 12-hour shift (6:00 AM to 6:30 PM/6:00PM to 630AM) on a rotating 2-2-3 schedule.  Note that this schedule does include working alternating weekends and holidays

• Must be able to successfully pass and maintain aseptic gowning qualification.  Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, 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

• Must be willing to work various shifts

• Computer literacy (internet browsers, e-mail, spreadsheets, word processing)

• Experience with batch record execution, including good documentation practices

Preferred Experience and Skills:

• Bachelor’s degree in Life Science or Engineering

• Associate’s degree in Life Science or Engineering