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• Sterility Assurance support for the Aseptic Process Simulation program, training, and protocol according to local and/or global responsibilities
• Contamination control strategy according to Annex 1
• Technical sterility assurance expertise: consultation and education
• Environmental monitoring and trending according to local and/or global responsibilities
• Regulatory expertise locally
• General aseptic program
• Cleaning and disinfection program
• Container closure integrity
• Quality Risk Management

• The role holder is responsible for prioritization, organization and communication of workload and issues/resolutions through appropriate forums and representation of the Site at a global level.
• Provide leadership to the site related to Sterility Assurance standards, culture, and continuous improvement.
• Partner closely with the global function as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to Sterility assurance governance and drive improvements.
• Provide oversight of quality standards and systems aligned with the Sterility Assurance function in the above areas for the site.
• Set objectives and provide clear direction for execution within area of responsibility.
• Implement and drive a learning culture and ensure a vertical and horizontal knowledge management.
• Partner closely with his or her peers in Global and Local Sterility Assurance from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Enterprise manufacturing sites to drive standardization.
• The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the Enterprise organization.

This position reports to:  Regional Lead - Sterility Assurance

Reporting to this position: None

Main Responsibilities and Accountabilities:

Safety

• Contribute to the improvement of safety and the safety culture as a role model.
• Encourage your employees to take an active part in the continuous improvement of our safety and safety culture.

Leadership

• Provide guidance to the local team of Sterility Assurance professionals at the CSL Enterprise global manufacturing sites.
• Provide strategic leadership to the site engineering, validation, operations, and quality functions related to sterility assurance.
• Support Regional Lead in Individual Performance Management: Develop, agree, and evaluate the divisional objectives.
• Together with regional lead, site head and site Quality head, develop and agree site objectives related to sterility assurance.
• Provide input for organizational design and staffing decisions. Plan optimal use of resources (staff, material, equipment, and rooms) to ensure efficient and effective achievement of objectives.
• Support employee engagement through clear direction for execution, support development of staff through training, further education, delegation of duties and continuous improvement
• Support team spirit and motivation of staff on site by means of an open feedback culture and recognition of achievements.
• Oversee the ongoing education and development of employees together with regional lead.

Technical duties

• Work collaboratively with the Global SA team to provide a holistic microbial contamination control strategy and improvement plan at the CSL Enterprise 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 programs etc.).
• Use knowledge of the facility, process, and equipment to design the validation controls on an aseptic facility including, aseptic media fill simulation program (including risk assessment of interventions), container closure integrity, validation and re-validation of the HVAC and HEPA system, smoke studies, etc.
• Use knowledge of the facility, process, and equipment to design the microbiological controls of the aseptic facility including the environmental monitoring program, in-process monitoring and finished product monitoring, including the use of new methods and new technology (Rapid microbiology methods).
• Establishment and maintenance of GEMBA processes for critical cleanliness and aseptic behavior
• Provide expert input to deviation investigation in sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail.
• Support to 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.
• Escalate emerging trends and/or changes in site performance and in regulatory guidance to key stakeholders, through tiered accountability, Site Quality Council and Quality Management Review Meetings.  To ensure that all the operational areas are also fully aware of results obtained and trends that are developing and ensuring that they can contribute to root cause investigations. Active communication to global network to ensure that corrective actions are harmonized across the entirety of the Enterprise network.  Participate in the Global Sterility Assurance Oversight forum representing the site and communicating to senior stakeholders on Sterility Assurance issues.

Qualifications:

• Bachelor’s degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences). Advanced degree (Masters/Ph.D.) preferred.
• Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, to include design, validation and monitoring, life cycle management and cGMP compliance.

• +7 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing.
• Extensive professional experience in supporting teams with respect to aseptic cleanrooms, process, equipment, consumables and utilities, validation, and microbiological monitoring.
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU, and other regulatory agency guidelines.
• 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.
• Experienced in Quality Risk Management.
• Strong leadership skills (influencing, negotiating, priority setting, timely decision-making) in addition to supporting staff by example, providing technical and personal support
• Demonstrated ability for conceptual and analytical thinking from a holistic system wide to detail view, with good judgement to reconcile ambiguities.

• Thinks beyond and maintains an external and strategic focus to take a proactive approach to sterility assurance to reduce the number of events and impact when they occur. 
• Ability to influence and motivate others at all organizational levels through clear, concise, and impactful verbal and written communication skills while maintaining a cohesive team environment.
• Ability to work collaboratively and pragmatically with others to ensure successful outcomes.
• The ability to aseptically gown and enter aseptic filling cleanrooms is preferred.
• In depth knowledge and experience of performing risk-based assessments and root cause investigations
• In-depth knowledge of cGMP’s, FDA, TGA, EU and other relevant GxP regulations including current knowledge of industry best practice with respect to sterility assurance principals
• Excellent verbal and written communication skills in the local language and English with the ability to effectively present within all levels of the organization, with external colleagues and collaborators and regulatory agencies
• Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.
• Excellent skills in critical review of documents, protocols, reports, and SOPs.
• Develop, Contribute and support local and global strategic plans.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Global travel may be part of this position.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.