Computer System Validation (CSV) Site Lead
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!
The Computer System Validation Specialist will be responsible for developing and executing the Computerized System Validation (CSV) deliverables for control systems within Execution Systems (ES) and interfaces. Responsible for the implementation of Execution Systems projects and programs at their respective site. Maintain the validated status of ES platforms for manufacturing site.
Main Responsibilities and Accountabilities:
Accountable for the implementation of CSV strategy across CSL
Manage the CSV program for Execution Systems and application interfaces.
Owner of change management procedures and processes in collaboration with Quality.
Owner of the ES validation strategy/validation master plan in alignment with Quality.
Oversee the preparation, delivery, and execution of CSV protocols.
Collaboration across the network:
Coordinate with Site and Global validation team to build alignment of ES validation expectations.
Partner with ES Project Execution team to ensure oversite of CSV activities associated with the project.
Develop processes and maintain platforms:
Responsible for the System Development Lifecycle and validated state of platforms.
Responsible for Data Integrity Assessment review and approval processes.
Accountable for the Periodic Review process for documentation and systems.
Support close-out activities and lead remediation in any areas relevant to ES driving initiatives to improve compliance and raise standards.
Use Application Lifecycle Management (ALM) platforms to support CSV phases.
Compliance and Audit Ownership:
Work with affiliate colleagues to ensure a state of audit/inspection readiness.
Support auditors and inspectors as required.
Process ownership for investigations, CAPAs, and quality and compliance KPIs.
Maintain Quality Standards:
Understand and apply basic concepts associated with measuring quality metrics.
Implement controls to support quality management.
Identify new approaches and techniques utilizing quality management to ensure quality levels.
Employ audits and inspections to maintain the product quality; correct the product, and process to meet quality standards.
Minimum a Bachelor's in Engineering, Computer Sciences, or similar field.
Master’s degree in Engineering and Computer Sciences preferred.
Experience and Capabilities:
7+ years' experience with CSV methodologies in operation IT, OT, or Automation position with a good understanding of pharma, biologic, chemistry, and food industries.
Demonstrated experience `working and influencing in a global matrix environment.
Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity.
Experience with Execution Systems technologies, including Data Historian Systems (OSI PI), SCADA, Process Control Systems (Siemens and Rockwell) , , Manufacturing Execution Systems (Werum and OpCenter), Laboratory Information Management Systems (LIMS), Building and Facilities Management Systems (BMS/FMS) and interfaces to ERP (SAP) and other enterprises platform.
Experience implementing compliance and risk-based approach best practices.
Experience with Automation and MES projects and computer validation methodologies.
Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
Experience using ALM platforms such as QC Vera and Codebeamer to support CSV.
Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems
Strong communication and conflict management skills to influence project professionals and stakeholders, including non‐specialists, at all levels in the organization.
Strong skills in managing, organizing, developing and deploying best practice frameworks, processes, tools, and templates in an Operations context, in alignment with Enterprise standards.
Thinks beyond and helps teams respond to the external environment.
Proactively improves cross-business collaboration.
Strong understanding of US, European, and or Australian applicable regulations