Position Summary

The Cleanroom Manufacturing Technician supports sterile injectable manufacturing operations by performing aseptic production, filling, compounding, packaging, and documentation activities in a controlled cleanroom environment. This role ensures compliance with FDA regulations, cGMP requirements, USP <797>/<800> standards, and Medivant Healthcare quality procedures while supporting safe, efficient, and compliant manufacturing operations.

Key Responsibilities

Manufacturing Operations

• Perform aseptic manufacturing, compounding, filling, and packaging activities.
• Operate and monitor manufacturing equipment, including filling machines, autoclaves, and compounding tanks.
• Prepare materials and equipment for production batches.
• Maintain cleanroom standards, gowning requirements, and personnel hygiene practices.
• Support environmental monitoring and routine equipment cleaning.

Documentation & Compliance

• Complete Batch Manufacturing Records (BMRs), logbooks, and production documentation accurately.
• Follow Good Documentation Practices (GDP) and cGMP requirements.
• Maintain manufacturing records in compliance with FDA and company standards.
• Support audit readiness and inspection activities.

Quality & Team Collaboration

• Follow all safety, quality, and compliance requirements.
• Report deviations, equipment issues, and quality concerns promptly.
• Collaborate with Quality, Operations, and Manufacturing teams to meet production schedules.
• Participate in training and continuous improvement initiatives.
• Perform additional duties as assigned.

Qualifications

Required

• High school diploma or GED.
• Strong attention to detail and commitment to quality.
• Ability to work in a cleanroom environment and wear required PPE.
• Strong teamwork and communication skills.
• Ability to stand for extended periods and lift up to 25 lbs.

Preferred

• Experience in pharmaceutical manufacturing, sterile compounding, or cleanroom operations.
• Familiarity with FDA-regulated and cGMP environments.
• Technical or vocational training in science, healthcare, or manufacturing.

Key Competencies

• Aseptic Processing
• Cleanroom Operations
• cGMP Compliance
• Documentation Accuracy
• Quality Focus
• Attention to Detail
• Teamwork & Communication
• Safety Awareness
• Problem Solving
• Continuous Improvement

What Success Looks Like

• Manufacturing activities are completed safely, accurately, and on schedule.
• Documentation is maintained with full compliance and accuracy.
• Cleanroom and aseptic standards are consistently followed.
• Quality and regulatory requirements are met without deviation.
• Strong collaboration supports efficient production and operational excellence.