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.