Sterility Assurance Validation SME
- CSL Behring
- Kankakee, Illinois
- Start date
- Mar 20, 2023
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- BioMidwest, Best Places to Work
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
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
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!
As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.
CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.
CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!
Stock Symbol: CSL
Stock Exchange: Australian Securities Exchange
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