Aseptic Operator
About The Position
The Aseptic Operator is responsible for supporting sterile manufacturing operations by performing aseptic processing activities in compliance with GMP requirements. This role plays a critical part in maintaining product quality and contamination control within cleanroom environments. This position is well-suited for someone who is detail-oriented, dependable, and comfortable working within strict procedures and controlled conditions. Success in this role comes from focus, consistency, and the willingness to stop and escalate when something does not look right.
Requirements
- High school diploma or equivalent
- Experience working in a GMP-regulated manufacturing environment, preferably sterile or aseptic processing
- Ability to follow detailed procedures and instructions consistently
- Strong attention to detail and documentation accuracy
- Comfort working in cleanroom environments while wearing full gowning and PPE
- Dependable attendance and clear communication
Nice To Haves
- Previous experience in aseptic filling, sterile compounding, or sterile manufacturing operations
- Familiarity with cleanroom classifications and aseptic technique principles
- Experience supporting inspections or audits in regulated environments
Responsibilities
- Perform aseptic manufacturing activities in accordance with approved SOPs and GMP requirements
- Follow gowning, hygiene, and contamination control procedures required for cleanroom operations
- Set up, operate, and monitor manufacturing equipment used in aseptic processes as trained
- Accurately complete batch records, logs, and other production documentation in real time
- Monitor process conditions and product handling to ensure compliance with aseptic technique
- Identify and escalate deviations, equipment issues, or potential contamination concerns promptly
- Participate in cleaning, sanitization, and line clearance activities
- Support environmental monitoring and sampling activities as required
- Work collaboratively with Manufacturing, Quality Assurance, and support teams
- Participate in training, qualification, and continuous improvement activities
Benefits
- A stable, quality-focused work environment
- Clear expectations and structured training
- Hands-on experience in sterile manufacturing operations
- The opportunity to contribute directly to product quality and compliance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
11-50 employees
