Role: Production Technician
Location: Durham, NC
Duration: 12 month
Schedule: The hours will fluctuate weekly between either 8:00AM - 4:00PM and 3:00PM - 11:00PM
Overview: Join our Manufacturing Operations team dedicated to producing high-quality therapies for patients. This role involves working in a dynamic environment focused on safety and quality, contributing to the end-to-end processing of drug substances and products while fostering a culture of continuous improvement and teamwork.
Key Responsibilities:
- Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations
- Identify and address compliance, environmental, safety, and process deviations while coordinating with appropriate personnel
- Actively participate in team meetings, HAZOPS, waste walkthroughs, 5S, kaizen events, and other training/initiatives
- Execute and own production targets for assigned areas, including cleaning, setup, operation, and troubleshooting of equipment
- Maintain excellent recordkeeping and housekeeping
- Drive a culture of continuous improvement by implementing and raising ideas to increase group success
- Participate in activities supporting technical and OPEX functions such as Kaizen events and protocol execution
- Maintain detailed knowledge of equipment and processes
Required Qualifications:
- High School Diploma/GED or higher
- Minimum of one (1) year of experience in a relevant field
- Demonstrated written and verbal communication skills
- Ability to successfully pass and maintain aseptic gowning qualifications
- Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
- Willingness and ability to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
- Successful completion of TB titer and Chest X-ray are required
Preferred Qualifications:
- Minimum Associate's Degree in science or related field
- BioWork Certificate (working in an FDA or similar regulated industry)
- Applicable mechanical and project management experience
- Experience with automated systems (MES, SAP, DeltaV, or similar)
- Familiarity with regulatory requirements and Good Documentation Practices (GDP)
- Demonstrated ability to work both independently and as part of a team
- Aseptic behaviors and techniques, cRAB/Isolator experience, and environmental monitoring experience are significant advantages
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Spectraforce Technologies
Oct 20, 2026