Cleanroom Manufacturing Technician

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.