Sterility Assurance Monitoring Controls SME
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
- 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 validation activities affecting sterile manufacturing (Fill / Finish area incl. filling, lyophilizers, sterilizers, isolator technology and auxiliary equipment, personnel training and qualification, cleaning and disinfection programmes etc) to include EMPQ, media fill simulations programme, container closure integrity programme, bacterial filter validation and disinfectant validation
- Support local and global capacity expansion/new projects to ensure reliable supply for our patients
- Establishment and maintenance of quality on the floor processes for critical cleanliness and aseptic behavior
- 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, SOPs, risk assessments, etc in the areas relating to sterility assurance validation, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the global network.
- 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, and personnel to include design and use and 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 aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning and utilities
- 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