Sterility Assurance Validation SME
Company: CSL Behring
Posted on: January 15, 2022
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
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
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
Ensure that global standards are met for best practice
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
+5 years of experience in the pharmaceutical manufacturing industry
with direct experience in sterility assurance of aseptic
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
Experience in the manufacturing of biologics
Direct experience executing Quality Assurance function and system
within a manufacturing and QC Microbiology/Sterility Assurance
Experience in interacting with regulatory authorities including
submissions and inspections
Knowledge of auditing practices and procedures
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.
About CSL Behring
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 .
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL
embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!
Keywords: CSL Behring, Joliet , Sterility Assurance Validation SME, Other , Kankakee, Illinois
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