Operations Technician I (3rd Shift, 9p-6a)

Position Summary

The Operations Technician is responsible for supporting pharmaceutical manufacturing operations including compounding, filling, finishing, and prep activities. This position ensures the production of high-quality pharmaceutical products in compliance with cGMP requirements and FDA regulations through hands-on manufacturing support, equipment operation, and detailed documentation.

Job Responsibilities

• Perform compounding activities including weighing, mixing raw materials, and executing batch operations
• Operate and monitor production line equipment for filling operations and make necessary adjustments per QA requirements
• Execute finishing activities including packaging, labeling, and product inspection for quality assurance
• Complete sterile filtration, steam sterilization, and conduct filter integrity tests
• Perform line changeovers, equipment set-up, and basic troubleshooting
• Document batch records and production documentation with attention to detail using cGMP techniques
• Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMP)
• Collect samples for Quality Assurance testing and report process deviations to supervisors
• Maintain clean room environment and comply with garbing requirements
• Perform equipment calibrations and verifications (balances, pH meters)
• Assist with materials management, inventory tracking, and line clearance activities
• Clean and sanitize equipment and manufacturing areas
• Follow safety procedures and wear required PPE
• Update SAP systems and maintain accurate production records

Experience Requirements

• Excellent attention to detail and basic math skills required
• Good verbal and written communication skills
• Strong organization, time-management, and problem-solving abilities
• Mechanically inclined with ability to troubleshoot equipment issues
• Physically able to lift 50 lbs and stand for extended periods (up to 8 hours)
• Ability to work flexible schedule including early shifts (3am-5am start times)
• Documented vision of 20/20 (corrective lenses permitted) for inspection activities
• Good hygiene and ability to work in clean room environment
• Manufacturing experience preferred but not required

Education Requirements

• High School diploma or equivalent required. Associate degree with scientific background preferred.