Sr. Specialist, Sterility Assurance

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

 

• Subject Matter Expert (SME) for development, implementation, monitoring and improvement of Aseptic Processing Simulation (Media Fill) Program, aspetic sample collection process during bulk/formulation activities, and closed system integration.
• Evaluate manufacturing operational practices and strategies to ensure compliance with regulatory requirements.
• Lead, develop, implement, and influence changes to meet requirements and continuously improve sterility assurance processes.
• Ability to identify and report on Quality events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance.
• Support the training and qualification program for aseptic techniques, and behaviors.
• Oversight of the Media Fill program at the Indianapolis facilities and sharing best aseptic practices at other Millipore Sigma manufacturing sites.
• Must Maintain aseptic gown training and be an extension of quality and training within the aseptic areas to monitor and reinforce best aseptic practices.
• Evaluate manufacturing operational practices to ensure compliance with regulatory requirements, identify risk and implement changes to meet requirements including but not limited to PUPSIT integration, CCIT methods, and closed system processes.
• Evaluate CCIT practices to ensure compliance with regulatory requirements, and ensure methods are adequately designed and operated for sterility assurance.
• Develop and evaluate Media Fill Qualification to demonstrate facilities are adequately designed and operated for sterility assurance.
• Overseeing aseptic simulations (media fills) and smoke studies. Maintain and improve SOPs for each of these programs.
• Provide support for aspetic sample collection process and site aspectic behavior.
• Evaluate material transfer practices and critical intervention behaviors for compliance to aseptic regulations and continuous improvement.
• Act as SME and interface directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics.
• Support the Aseptic Processing protocols, summary reports, risk assessments, investigations, change control, corrective action, and preventive action (CAPAs) in a timely manner.
• Provide technical guidance for all questions and issues related to sterility assurance, aseptic processing, RABS/isolators, material transfer, and room fumigation with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place.
• Support the clean room qualifications and re-qualifications Provide technical guidance for all questions and issues related to sterility assurance, aseptic processing, RABS/isolators, material transfer and room fumigation.

 

Who You are:

 

 

Minimum Qualifications:

• Bachelor’s Degree in Microbiology, Biology, or other Life Science discipline.
• 4+ years of experience in a GMP environment working with environmental monitoring of aseptic processing and sterility assurance systems.

 

Preferred Qualifications:

• Experience with aseptic techniques within cleanrooms, aseptic sample collection, material transfers, bioburden control and closed system processes.
• Experience with execution of validation process associated with Media Fill Simulations