Job Summary:

The Aseptic Specialist is a Quality-owned position embedded within Manufacturing Operations to promote and sustain excellence in aseptic processing. This role serves as a collaborative partner to production personnel, providing real-time coaching, guidance, and oversight to ensure operators consistently perform in accordance with approved smoke studies, aseptic techniques, and laminar airflow (LFH) principles.

The Aseptic Specialist is not intended to function as an auditor or inspector, but rather as a technical resource and mentor who works alongside Operations to reinforce best practices, identify opportunities for improvement, and help maintain a robust state of contamination control.

Responsibilities:

First Air and Smoke Study Compliance

• Observe aseptic operations to ensure operator activities remain consistent with validated smoke studies.
• Reinforce first air principles and immediately coach operators when practices could disrupt unidirectional airflow.
• Promote consistent execution of validated aseptic techniques during all production activities.

Laminar Flow Hood (LFH) Setup

• Verify proper arrangement of materials, equipment, and supplies within ISO 5 workspaces.
• Assist operators in optimizing hood setup to maintain first air and minimize airflow disruption.
• Recommend improvements to workstation organization based on smoke study observations and operational efficiency.

Real-Time Aseptic Coaching

• Provide immediate, respectful coaching to operators during routine manufacturing activities.
• Reinforce proper aseptic behaviors while recognizing and encouraging exemplary technique.
• Identify recurring opportunities for improvement and communicate trends to Quality and Operations leadership.

Independent Personnel Monitoring

• Perform non-biased personnel monitoring, including fingertip and gown sampling.
• Ensure personnel monitoring accurately reflects operator performance while maintaining consistency and objectivity.
• Assist with qualification and requalification activities for aseptic operators.

Continuous Process Improvement

• Partner with Quality and Operations to improve aseptic processes, workflows, and contamination control practices.
• Participate in investigations, CAPAs, risk assessments, smoke study reviews, and contamination control initiatives as needed.
• Recommend improvements to Standard Operating Procedures (SOPs), batch records, training materials, and other controlled documents to strengthen compliance and operational efficiency.

Required Skills/Abilities/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.
• Experience working within GMP-regulated pharmaceutical manufacturing preferred.

Required Skills

• 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.

Core Competencies

The successful candidate will:

• Serve as a collaborative bridge between Quality and Manufacturing Operations.
• Foster a culture of continuous learning rather than compliance through enforcement alone.
• Lead by example through professionalism, technical expertise, and respectful communication.
• Be approachable, supportive, and willing to work alongside operators to solve problems.
• Demonstrate initiative in identifying opportunities to improve aseptic practices, SOPs, batch records, workflows, and training programs.
• Promote continuous improvement while maintaining the highest standards of sterility assurance and contamination control.

Success Measures

Success in this role will be demonstrated by:

• Improved operator compliance with smoke study practices and first air principles.
• Consistent and optimized LFH setup across all manufacturing operations.
• Reduction in aseptic technique observations, environmental monitoring excursions, and operator-related deviations.
• Increased consistency in personnel monitoring results.
• Successful implementation of process improvements through collaboration with Operations and Quality.
• Positive feedback from operators and leadership regarding coaching, communication, and technical support.

Education and Experience:

Physical Requirements: