Cleanroom Manufacturing Technician
Tailstorm Health Inc
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 / standards, and Medivant Healthcare quality procedures while supporting safe, efficient, and compliant manufacturing operations.
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 / 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.
Requirements
- 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
- 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
Company overview
Tailstorm Health Inc is a pharmaceutical manufacturing company operating in the healthcare sector. As a pharmaceutical organization, the company is involved in the research, development, and production of medicinal drugs and therapeutic products. Pharmaceutical companies like Tailstorm Health play a crucial role in the healthcare ecosystem by creating innovative treatments for various medical conditions, conducting clinical trials, and ensuring regulatory compliance for drug safety and efficacy. The company's operations likely encompass drug discovery, formulation development, manufacturing processes, quality control, and distribution of pharmaceutical products to healthcare providers and patients. In the competitive pharmaceutical landscape, companies must navigate complex regulatory environments, intellectual property considerations, and market dynamics while maintaining high standards for product quality and patient safety.