Manufacturing Technician

Job Description

Job Posting Title - Cleanroom Manufacturing Technician

Job Description

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

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

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

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

Required

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

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

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

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