Sterility Assurance Validation SME

Reporting into the Sterility Assurance Lead, the Quality Sterility Assurance Monitoring Controls SME will be responsible for the leadership, oversight and life cycle management for the contamination control monitoring control governance to include: Environmental and Personnel monitoring, In-process testing, finished product testing, microbiological method development and pest control.

• Work collaboratively with the Global SA team and Local SA team to provide a holistic microbial contamination control strategy and improvement plan at the CSL Behring Manufacturing site.
• Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
• Collaborate with internal and external partners for the design of best practice sterility assurance controls for the microbial contamination control strategy and life cycle management – to deliver on time and to the required standards and regulatory requirements with respect to monitoring activities affecting sterile manufacturing, cleanrooms, personnel, in-process and finished product testing.
• Support local and global capacity expansion/new projects to ensure reliable supply for our patients
• Support regulatory document submissions, internal and external (pre-approval and routine) GMP inspections as SME. Responsibility for responding to inspection observations relating to sterility assurance.
• Responsible for the generation of the documentation (IQ/OQ/PQ documents for microbiological method validation (sterility testing, bioburden and endotoxin), SOPs, risk assessments, trend reports, objectionable organism review, alert and action in house limit review etc. to ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the global network.
• Support the local site in any deviations related to microbial contamination.
• Ensure that global standards are met for best practice

• Education

  Degree in Microbiology/biology life sciences. 

• Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, to include microbiological monitoring, design of EM programmes, trending and microbiological method validations (sterility, endotoxin and bioburden), life cycle management and cGMP compliance.
• +5 years of experience in the pharmaceutical manufacturing industry with

  direct experience in sterility assurance of aseptic processing

• Extensive professional experience in leading teams with respect to microbial monitoring of aseptic cleanrooms, processes, equipment, consumables and utilities, in-process and finished product testing and personnel monitoring.
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
• Experience in the manufacturing of biologics
• Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context.
• Experience in interacting with regulatory authorities including submissions and inspections
• Knowledge of auditing practices and procedures

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.