Katalyst CRO
Senior CSV Engineer – Katalyst CRO
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Summary
Proficiency in Google Suite (G Suite).
Basic knowledge of SAP, MES systems, and their interfaces.
Ability to explain complex concepts with clarity and simplicity.
Strong detail orientation and high degree of accuracy.
Strong verbal, written, and interpersonal communication skills.
Roles and Responsibilities
Collaborate closely with Product Owner, Scrum Master, Architects, Configuration Specialists, and Tester Team Leads.
Determine validation approach and identify deliverables needed or impacted by project enhancements or changes for GxP computerized systems and infrastructure.
Review software documentation according to CSV corporate SOPs and regulatory guidance.
Provide estimates and forecasts for validation activities within a project.
Author validation plans and reports; review test plans, test reports, and other deliverables to assess system readiness for go‑live.
Define testing strategy, requirements, and acceptance criteria.
Liaise with Business Quality and Informatics Quality to ensure compliance with corporate quality policies and standards.
Coordinate and advise on all validation activities at a global organizational level for system projects.
Participate in validation discussions and provide consultancy for all validation‑related questions.
Participate in system implementation and maintenance planning.
Lead and author system and functional risk assessments.
Verify testing plans, activities, deliverables, and records; provide consultancy on test‑related deviations and corrective actions.
Review and collect required CSV deliverables, records, and evidence according to plans.
Prioritize activities in line with project schedules, business needs, and compliance requirements.
Ensure code release‑to‑production and maintenance procedures are defined and followed.
Confirm initial data loading or data migration from other systems is executed per approved procedures.
Assess changes for potential impact on the validated state of computerized systems.
Support system maintenance to ensure validated state and continuous audit readiness.
Lead and author periodic system reviews in accordance with procedures.
Observe governance processes and elevate areas for improvement.
Support audit and inspection preparation and execution as a CSV subject‑matter expert.
Provide strategic oversight over validation support within the department and offer consultancy across the global organization.
Implement relevant frameworks and processes; propose and use supporting tools.
Provide training, validation quality knowledge sharing, and experience exchange.
Prepare recommendations for process optimization within the area of responsibility.
Provide input and guidance for computerized system retirement planning.
Qualifications
7+ years of experience in IT & Software Validation (CSV, GAMP).
Strong detail orientation and high degree of accuracy.
Strong verbal, written, and interpersonal communication skills.
Ability to explain complex concepts with clarity and simplicity.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Engineering and Information Technology
Industries
Civil Engineering
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Summary
Proficiency in Google Suite (G Suite).
Basic knowledge of SAP, MES systems, and their interfaces.
Ability to explain complex concepts with clarity and simplicity.
Strong detail orientation and high degree of accuracy.
Strong verbal, written, and interpersonal communication skills.
Roles and Responsibilities
Collaborate closely with Product Owner, Scrum Master, Architects, Configuration Specialists, and Tester Team Leads.
Determine validation approach and identify deliverables needed or impacted by project enhancements or changes for GxP computerized systems and infrastructure.
Review software documentation according to CSV corporate SOPs and regulatory guidance.
Provide estimates and forecasts for validation activities within a project.
Author validation plans and reports; review test plans, test reports, and other deliverables to assess system readiness for go‑live.
Define testing strategy, requirements, and acceptance criteria.
Liaise with Business Quality and Informatics Quality to ensure compliance with corporate quality policies and standards.
Coordinate and advise on all validation activities at a global organizational level for system projects.
Participate in validation discussions and provide consultancy for all validation‑related questions.
Participate in system implementation and maintenance planning.
Lead and author system and functional risk assessments.
Verify testing plans, activities, deliverables, and records; provide consultancy on test‑related deviations and corrective actions.
Review and collect required CSV deliverables, records, and evidence according to plans.
Prioritize activities in line with project schedules, business needs, and compliance requirements.
Ensure code release‑to‑production and maintenance procedures are defined and followed.
Confirm initial data loading or data migration from other systems is executed per approved procedures.
Assess changes for potential impact on the validated state of computerized systems.
Support system maintenance to ensure validated state and continuous audit readiness.
Lead and author periodic system reviews in accordance with procedures.
Observe governance processes and elevate areas for improvement.
Support audit and inspection preparation and execution as a CSV subject‑matter expert.
Provide strategic oversight over validation support within the department and offer consultancy across the global organization.
Implement relevant frameworks and processes; propose and use supporting tools.
Provide training, validation quality knowledge sharing, and experience exchange.
Prepare recommendations for process optimization within the area of responsibility.
Provide input and guidance for computerized system retirement planning.
Qualifications
7+ years of experience in IT & Software Validation (CSV, GAMP).
Strong detail orientation and high degree of accuracy.
Strong verbal, written, and interpersonal communication skills.
Ability to explain complex concepts with clarity and simplicity.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Engineering and Information Technology
Industries
Civil Engineering
#J-18808-Ljbffr