Aseptic Specialist
$58,240–$58,240 year
On-siteDenver, Colorado, United States
Job Summary
Observe aseptic operations to ensure operator activities align with validated smoke studies and laminar airflow principles. Reinforce first air practices by coaching operators during routine manufacturing activities and verifying proper material arrangement within ISO 5 workspaces. Perform independent personnel monitoring, including fingertip and gown sampling, while assisting with qualification and requalification for aseptic operators. Partner with Quality and Operations to improve workflows, recommend SOP enhancements, and participate in investigations and risk assessments. Foster a culture of continuous learning and collaboration to reduce deviations and optimize contamination control practices.
Required Qualifications
- Demonstrated knowledge of aseptic processing principles and contamination control
- Qualified to enter classified manufacturing areas, including successful gowning qualification
- Successfully qualified through aseptic process simulation (Media Fill) requirements
- Strong understanding of first air principles, smoke study interpretation, and laminar airflow concepts
- Excellent verbal and written communication skills
- Ability to effectively communicate with personnel at all organizational levels
- Strong interpersonal skills with the ability to coach, mentor, and influence others in a positive and professional manner
- Ability to build trust and maintain strong collaborative relationships between Quality and Operations
- Strong observational skills with attention to detail
- Ability to remain objective while providing constructive feedback
- Excellent technical writing skills for documenting observations, recommendations, and process improvements
- Associate or Bachelor's degree in related life sciences
- 2+ years of experience in cGMP Manufacturing environment and/or cleanroom setting
Desired Qualifications
- Experience working within GMP-regulated pharmaceutical manufacturing preferred
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