Computer System Validation Specialist

About CSL

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!

Job Description

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:

Design, modify, develop, write, review, and implement all Computer System Validation (CSV) documents, protocols, and reports for validation and qualification work.

Support maintenance and evolution of Standard Operating Procedures (SOP) for computerized and manufacturing systems. Generate changes reports or documents for new or modified equipment .

Validates and coordinates all CSV activities by constant communication with affected departments; oversees and reviews validation area processes and procedures; Review and approve computer system change controls, discrepancies, CAPAs

Maintain change management procedures and processes in collaboration with Quality.

This position is responsible for ensuring cGMP/Regulatory compliance with internal/external policies and, guidelines, including internal SOP's, departmental standards and conventions.

Develop and execute CSV deliverables, as per the System Development Life Cycle (SDLC), such as Validation Planning, URS, SDS, Testing, Traceability Matrix, and Final Reporting for industrial control systems including SIMATIC PCS 7, distributed control system, PLCs, and SCADA.

The resource will also participate in the execution of gap assessment and remediation activities for the Data Integrity initiatives within CSL manufacturing sites.

Provide support to internal and external audits and experience with audits readiness and pressure test. Support sites during health authority inspection as required, e.g., describing the validation approaches across multiple locations, expert input into questions related to CSV.

Participate in assessing system reviews, deviations, CAPA, Changes, continuous improvement, and troubleshooting related to Global ES Systems and Applications.

Monitor compliance adherence of ES platforms both globally and locally with the sites.

Coordinate CSV/SDLC training and education to ES teams.

Education:

Minimum a Bachelor's in Engineering, Computer Sciences or similar field

Experience and Capabilities:

• 5+ years experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry, and food industries.
• Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk based approach.
• Experience with Automation and MES projects and computer validation methodologies.
• Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ) and CSV inspection readiness preparations and/or directly support regulatory agency inspections.
• Exposure to Execution Systems technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control, workflow, database applications, and interfaces to ERP, LIMS, etc.
• Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.

• Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems
• Understanding of business and manufacturing logistics and processes.
• Proven ability to work within and contribute to a high performing team.
• Self-motivated, demonstrates initiative, propensity to drive change
• Detail oriented, with strong written and verbal communication skills.
• Strong understanding of US, European, and or Australian applicable regulations