Manufacturing Operator

Key Responsibilities:

• Executes quality and manufacturing procedures to meet production demands and regulatory requirements.
• Ensures on-time production of pharmaceutical intermediates, semi-finished, and finished products meeting quality standards.
• Assists in setting up equipment operating specifications, SOPs, and improving manufacturing techniques.
• Supports equipment maintenance, calibration, and troubleshooting.
• Night Shift
  
  Hours:
  
  Alternating Wednesdays, plus every Thursday, Friday, and Saturday from 6:00 PM – 6:30 AM.
• Performs semi-routine tasks requiring judgment in problem-solving and recommendations.
• May guide lower-level personnel on assignments.
• Executes manufacturing operations per Manufacturing Records, cGMP, and SOPs in a cleanroom environment.
• Sets up, cleans, and sanitizes manufacturing areas and equipment under supervision.
• Operates production equipment per Manufacturing Records and SOPs (with supervision).
• Conducts in-process inspections and testing (with supervision).
• Accurately documents manufacturing activities in records, forms, labels, and logbooks.
• Verifies and confirms manufacturing steps performed by others.
• Follows all company health, safety, and environmental guidelines.
• Other tasks as assigned.

• High School/GED + 3-5 years of related experience (or equivalent training).
• Must pass medical clearance to wear a respirator (PAPR) for full shifts.
• Must be able to gown/de-gown in 3 layers of cleanroom attire (Tyvek® jumpsuit).
• Must comply with regulatory standards (FDA, ISO 13485, etc.).

• 12-hour shift availability.
• 20% Shift Differential.
• Experience in production/manufacturing.
• Comfortable wearing Tyvek suit & respirator.
• Schedule:
  
  3 days one week, 4 days the next (with OT on 4-day weeks).