Manufacturing Specialist

Shift: 2nd Shift (2:00 PM–12:00 AM)
Work Environment: Onsite only Bloodborne Pathogens: No

This role supports routine clinical manufacturing operations at the Norton Manufacturing Facility. Under direct supervision, the Manufacturing Contractor ensures safe, efficient, and cGMP‑compliant operations. Responsibilities include operating production equipment, performing cleaning and preparation tasks, and supporting material flow within manufacturing suites. The position requires frequent interaction with Facilities, QC, QA, Materials Management, and EHS.

• Shift Lead in place
• Typical team size: 8
• Current team size: 6

• Perform routine clinical manufacturing operations in compliance with cGMP requirements.
• Operate production equipment for weigh/dispense, solution preparation, CIP/COP, and small‑parts cleaning.
• Stock materials and maintain inventory within manufacturing suites.
• Follow SOPs for production of clinical products.
• Document all work clearly and accurately on approved forms and records.
• Collaborate with support groups (Facilities, QC, QA, Materials Management, EHS) to ensure timely completion of activities.
• Perform strenuous, sometimes repetitive physical work in a classified cleanroom environment.
• Lift up to 50 lbs and push/pull up to 250 lbs with assistance.
• Wear half‑face and full‑face respirators/PAPR as required for chemical processing.

• 0–3 years of experience.
• Mechanical and scientific aptitude.
• Strong attention to detail in both operations and documentation.
• Ability to perform physically demanding work on a manufacturing shift schedule.
• Strong time‑management skills and ability to work effectively in a team environment.

• Biotech Certificate or 2‑year degree with 1+ year of industry experience.
• GMP experience.
• Manufacturing background (biotech not required).
• Experience with MS Office Suite.
• Exposure to Delta
  
  V or other process automation systems.