Aseptic Specialist

STAQ Pharma

Denver (CO)

On-site

USD 70,000 - 95,000

Full time

11 days ago

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Job summary

STAQ Pharma seeks an Aseptic Specialist embedded in Manufacturing Operations to promote excellence in aseptic processing and to coach production personnel in validated smoke studies, aseptic techniques, and laminar airflow (LFH) principles.

The role focuses on real-time coaching, adherence to best practices, and collaboration with Quality and Operations to strengthen contamination control and continuous improvement.

Qualifications

Associate or Bachelor’s degree in life sciences.
2+ years of experience in cGMP manufacturing or cleanroom environments.
Qualified to enter classified manufacturing areas, including gowning qualification.
Experience with aseptic process simulations (Media Fill).

Responsibilities

Observe aseptic operations to ensure adherence to validated smoke studies and LFH principles.
Coach operators in maintaining first air and aseptic techniques.
Assist with setup of laminar flow hoods and work area organization.
Monitor personnel sampling and support qualification activities.
Identify opportunities for process improvements and report trends to Quality and Operations leadership.
Support investigations, CAPAs, and SOP updates as needed.

Skills

Aseptic processing

GMP compliance

Gowning qualification

Media Fill qualification

First air principles

Observation skills

Technical writing

Coaching/mentoring

Communication skills

Education

Associate or Bachelor's degree in life sciences

Job description

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