CSV Specialist

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.

Responsibilities:

• 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.

Position Qualifications and Experience:

Experience:

• 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.

Capabilities:

• 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

Education:

• Bachelor's in Engineering, Computer Sciences or similar field

Our Benefits

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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.

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