Aseptic Process Specialist

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13677738

## Who We Are

Since 1990, weve grown into a global leader in personalized medicine.

Today, our 5,000 energetic employees are based in 80 locations in

Europe, North America, South America, Africa and Asia-Pacificand are

working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and

genomics we deliver smart, ready-to-use solutions that make healthcare

better.

Were passionate, science-driven, and always looking for new ways to

improve lives. ??

Explore your future at[Fagron Career

Site](https://fagron.jobsmarket.site/pages/en-gb/jobs).

## About the Job

[The Specialist for the Aseptic Process Simulation Program organizes all

aspects of aseptic process simulation (APS) activities at the 503B

outsourcing facility. This individual coordinates the departments

responsible for the design, execution, and implementation of media-fill

protocols that qualify aseptic operations across multiple sterile areas

and production lines.]{contrast="none"}

[\

The Aseptic Process Specialist works with the Validation department

manager to ensure that all APS events are scientifically sound,

compliant with FDA 503B guidance, cGMP Guidance for Sterile

Manufacturing, and other relevant rules and guidelines, and that they

accurately simulate routine production practices. The coordinator will

report to Manufacturing Quality (MQ) and work with the MQ Aseptic

Training team to improve aseptic processes.]{contrast="none"}

**[Key Responsibilities]{contrast="none"}**

• [Coordinate the sites aseptic process simulation program, working
  
  

with Validation, Production and Quality Assurance to ensure it

remains compliant, efficient, and aligned with regulatory

expectations for 503B outsourcing facilities.]{contrast="none"}

• [Develop and approve media fill protocols that accurately model
  
  

production operations, including interventions, personnel

activities, and equipment configurations for each aseptic

line.]{contrast="none"}

• [Oversee the planning and real-time execution of approximately 2-4
  
  

media fills per month, ensuring adherence to validated procedures,

aseptic technique, and contamination control

principles.]{contrast="none"}

• [Coordinate cross-functional support from manufacturing, quality
  
  

control, and facilities.]{contrast="none"}

• [Ensure timely documentation, investigation, and closure of any
  
  

protocol deviations, failures, or environmental anomalies identified

during media fill events.]{contrast="none"}

• [Support the Aseptic Training team with analyzing performance trends
  
  

to identify opportunities for improving aseptic practices, reducing

risk, and optimizing fill efficiency.]{contrast="none"}

• [Work with the Aseptic Training team to ensure all involved in
  
  

executing the APS are appropriately trained and qualified in aseptic

technique, gowning, and simulation protocols.]{contrast="none"}

## Basic Qualifications

• [Bachelors degree in Microbiology, Life Sciences, Engineering, or
  
  

related discipline (advanced degree

preferred).]{contrast="auto"}[]{ccp-props="{"}

• [Minimum 5 years in sterile pharmaceutical manufacturing or 503B
  
  

compounding.]{contrast="auto"}[]{ccp-props="{"}

• [Understanding ofFDA 503B guidance, cGMP (21 CFR Parts 210/211), and
  
  

Guidance for Industry: Sterile Drug Products Produced by Aseptic

Processing current Good Manufacturing

Practice.]{contrast="auto"}[]{ccp-props="{"}

• [Leadership and project management
  
  

capabilities.]{contrast="auto"}[]{ccp-props="{"}

• [Communication, problem-solving, and decision-making
  
  

skills.]{contrast="auto"}[]{ccp-props="{"}

• [Proficiencyin electronic quality systems, deviation management, and
  
  

protocol/repor authorship.]{contrast="auto"}[]{ccp-props="{"}

• [Quality-driven and detail-oriented
  
  

mindset]{contrast="auto"}[]{ccp-props="{"}

• [Ability to lead and influence cross-functional
  
  

teams]{contrast="auto"}[]{ccp-props="{"}

• [Strong accountability and regulatory
  
  

awareness]{contrast="auto"}[]{ccp-props="{"}

• [Commitment to data integrity, compliance, and continuous
  
  

improvement]{contrast="auto"}[]{ccp-props="{"}

## What\'s on Offer?