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COMPUTER SYSTEM VALIDATION SPECIALIST (CSV)
Job Overview
We are seeking experienced Computer System Validation (CSV) Specialists to support the validation, implementation, maintenance, and lifecycle management of computerized systems within a regulated pharmaceutical manufacturing environment.
The ideal candidate will have hands-on experience executing computer system validation activities, developing and reviewing validation documentation, performing risk assessments, and ensuring compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and GMP standards.
This position will collaborate with Automation, Information Technology (IT), Engineering, Manufacturing, Quality Assurance, and system vendors to ensure computerized systems are appropriately validated, maintained in a controlled state, and capable of supporting reliable and compliant manufacturing operations.
Key Responsibilities
Computer System Validation & Lifecycle Management
• Plan, coordinate, and execute computer system validation activities throughout the system lifecycle, including implementation, upgrades, modifications, and periodic reviews.
• Develop, review, and execute validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Ensure computerized systems meet intended-use requirements, established acceptance criteria, and applicable regulatory expectations.
• Perform risk-based validation assessments to determine appropriate testing strategies, documentation requirements, and validation scope.
• Support the maintenance of computerized systems in a validated state throughout their operational lifecycle.
Automation & Manufacturing Systems
• Support validation activities for computerized systems associated with pharmaceutical manufacturing, process automation, laboratory operations, and quality management.
• Collaborate with Automation and Engineering teams on systems such as PLCs, SCADA, HMI, DCS, MES, and other manufacturing control platforms, as applicable.
• Review system configurations, functional requirements, interfaces, data flows, and automated process controls to ensure compliance with approved specifications.
• Support system implementation, upgrades, software changes, integrations, and troubleshooting activities from a validation perspective.
• Coordinate with system owners, vendors, and technical teams to evaluate system functionality and resolve validation-related issues.
Regulatory Compliance & Data Integrity
• Ensure validation activities comply with applicable FDA regulations, including 21 CFR Part 11, GMP requirements, and relevant GAMP 5 guidance.
• Evaluate computerized systems for data integrity controls, including audit trails, electronic records, electronic signatures, user access, security, and data retention.
• Apply ALCOA+ data integrity principles to computerized system documentation, testing, and operational controls.
• Participate in system assessments to identify compliance gaps and recommend appropriate corrective or preventive actions.
• Support internal audits, regulatory inspections, and quality assessments by providing validation documentation and technical justification.
Testing, Deviations & Change Control
• Develop and execute risk-based test scripts to verify system functionality, security, data integrity, and compliance with approved requirements.
• Document test results, discrepancies, deviations, and supporting evidence in accordance with established procedures.
• Investigate validation discrepancies, assess potential quality impacts, and coordinate corrective actions with appropriate stakeholders.
• Evaluate proposed system changes to determine validation impact, testing requirements, and documentation updates.
• Support change control activities associated with software modifications, system upgrades, configuration changes, and infrastructure improvements.
Documentation & Cross-Functional Coordination
• Maintain complete, accurate, and traceable validation documentation in accordance with applicable procedures and document control requirements.
• Coordinate validation deliverables, testing schedules, and system readiness activities with project teams and system owners.
• Participate in technical reviews, validation meetings, and project status discussions.
• Support the preparation and review of Standard Operating Procedures (SOPs), system administration procedures, and related lifecycle documentation.
• Provide technical support and guidance to cross-functional teams regarding CSV requirements, validation practices, and compliance expectations.
Qualifications & Requirements
Mandatory Qualifications
• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
• Hands-on experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, medical device, or other FDA-regulated environments.
• Experience developing, reviewing, and executing validation protocols and associated lifecycle documentation.
• Working knowledge of FDA 21 CFR Part 11, GMP regulations, GAMP 5, and computer system validation principles.
• Experience with risk assessments, requirements traceability, validation testing, deviations, and change control processes.
• Understanding of data integrity requirements, electronic records, electronic signatures, and computerized system controls.
• Ability to interpret technical specifications, system requirements, and validation documentation.
• Strong technical writing, analytical, problem-solving, and organizational skills.
• Ability to work effectively with multidisciplinary teams, including Automation, IT, Engineering, Manufacturing, and Quality.
• Excellent communication skills in English and Spanish.
Preferred Qualifications
• Previous experience validating manufacturing automation systems in pharmaceutical or biopharmaceutical facilities.
• Experience with PLC, SCADA, HMI, DCS, MES, or related industrial automation platforms.
• Familiarity with computerized systems supporting sterile manufacturing, packaging, laboratory operations, or process control.
• Experience with risk-based validation approaches and computerized system lifecycle management under GAMP 5.
• Knowledge of computerized system infrastructure, system interfaces, network architecture, and data management practices.
• Experience supporting regulatory inspections, internal audits, and remediation of computerized system compliance gaps.
• Familiarity with electronic validation management systems and computerized quality management platforms.
• Experience supporting commissioning, qualification, and integration activities for automated manufacturing equipment.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
We are seeking experienced Computer System Validation (CSV) Specialists to support the validation, implementation, maintenance, and lifecycle management of computerized systems within a regulated pharmaceutical manufacturing environment.
The ideal candidate will have hands-on experience executing computer system validation activities, developing and reviewing validation documentation, performing risk assessments, and ensuring compliance with applicable regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and GMP standards.
This position will collaborate with Automation, Information Technology (IT), Engineering, Manufacturing, Quality Assurance, and system vendors to ensure computerized systems are appropriately validated, maintained in a controlled state, and capable of supporting reliable and compliant manufacturing operations.
Key Responsibilities
Computer System Validation & Lifecycle Management
• Plan, coordinate, and execute computer system validation activities throughout the system lifecycle, including implementation, upgrades, modifications, and periodic reviews.
• Develop, review, and execute validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Ensure computerized systems meet intended-use requirements, established acceptance criteria, and applicable regulatory expectations.
• Perform risk-based validation assessments to determine appropriate testing strategies, documentation requirements, and validation scope.
• Support the maintenance of computerized systems in a validated state throughout their operational lifecycle.
Automation & Manufacturing Systems
• Support validation activities for computerized systems associated with pharmaceutical manufacturing, process automation, laboratory operations, and quality management.
• Collaborate with Automation and Engineering teams on systems such as PLCs, SCADA, HMI, DCS, MES, and other manufacturing control platforms, as applicable.
• Review system configurations, functional requirements, interfaces, data flows, and automated process controls to ensure compliance with approved specifications.
• Support system implementation, upgrades, software changes, integrations, and troubleshooting activities from a validation perspective.
• Coordinate with system owners, vendors, and technical teams to evaluate system functionality and resolve validation-related issues.
Regulatory Compliance & Data Integrity
• Ensure validation activities comply with applicable FDA regulations, including 21 CFR Part 11, GMP requirements, and relevant GAMP 5 guidance.
• Evaluate computerized systems for data integrity controls, including audit trails, electronic records, electronic signatures, user access, security, and data retention.
• Apply ALCOA+ data integrity principles to computerized system documentation, testing, and operational controls.
• Participate in system assessments to identify compliance gaps and recommend appropriate corrective or preventive actions.
• Support internal audits, regulatory inspections, and quality assessments by providing validation documentation and technical justification.
Testing, Deviations & Change Control
• Develop and execute risk-based test scripts to verify system functionality, security, data integrity, and compliance with approved requirements.
• Document test results, discrepancies, deviations, and supporting evidence in accordance with established procedures.
• Investigate validation discrepancies, assess potential quality impacts, and coordinate corrective actions with appropriate stakeholders.
• Evaluate proposed system changes to determine validation impact, testing requirements, and documentation updates.
• Support change control activities associated with software modifications, system upgrades, configuration changes, and infrastructure improvements.
Documentation & Cross-Functional Coordination
• Maintain complete, accurate, and traceable validation documentation in accordance with applicable procedures and document control requirements.
• Coordinate validation deliverables, testing schedules, and system readiness activities with project teams and system owners.
• Participate in technical reviews, validation meetings, and project status discussions.
• Support the preparation and review of Standard Operating Procedures (SOPs), system administration procedures, and related lifecycle documentation.
• Provide technical support and guidance to cross-functional teams regarding CSV requirements, validation practices, and compliance expectations.
Qualifications & Requirements
Mandatory Qualifications
• Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
• Hands-on experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, medical device, or other FDA-regulated environments.
• Experience developing, reviewing, and executing validation protocols and associated lifecycle documentation.
• Working knowledge of FDA 21 CFR Part 11, GMP regulations, GAMP 5, and computer system validation principles.
• Experience with risk assessments, requirements traceability, validation testing, deviations, and change control processes.
• Understanding of data integrity requirements, electronic records, electronic signatures, and computerized system controls.
• Ability to interpret technical specifications, system requirements, and validation documentation.
• Strong technical writing, analytical, problem-solving, and organizational skills.
• Ability to work effectively with multidisciplinary teams, including Automation, IT, Engineering, Manufacturing, and Quality.
• Excellent communication skills in English and Spanish.
Preferred Qualifications
• Previous experience validating manufacturing automation systems in pharmaceutical or biopharmaceutical facilities.
• Experience with PLC, SCADA, HMI, DCS, MES, or related industrial automation platforms.
• Familiarity with computerized systems supporting sterile manufacturing, packaging, laboratory operations, or process control.
• Experience with risk-based validation approaches and computerized system lifecycle management under GAMP 5.
• Knowledge of computerized system infrastructure, system interfaces, network architecture, and data management practices.
• Experience supporting regulatory inspections, internal audits, and remediation of computerized system compliance gaps.
• Familiarity with electronic validation management systems and computerized quality management platforms.
• Experience supporting commissioning, qualification, and integration activities for automated manufacturing equipment.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*