IT CSV Engineer
Evotec
21 days ago
Remote friendly (Redmond, WA)
United States
IT
What You'll Do
- Lead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative.
- Ensure adherence to client requirements, regulatory compliance, and project timelines.
- Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations.
- Develop validation strategies and author validation documents (validation master plans, data migration plans, protocols, reports, discrepancy resolutions).
- Manage and optimize validation testing processes using risk-based approaches aligned with FDA Computer Software Assurance (CSA) principles and GAMP5.
- Standardize and enhance CSV framework templates and procedures.
- Support risk management (risk-based assessments and gap remediation).
- Ensure compliance and maintain the validated state of all GxP systems.
- Manage external CSV consultants.
- Serve as SME for Data Integrity, CSV lifecycle management, and global regulatory compliance.
- Own CSV-related deviations and CAPAs.
- Partner with IT on backup/restore, disaster recovery, data retention schedules, and infrastructure qualification.
- Assist business/technical owners with requirements/specifications for GxP computerized systems.
- Oversee authoring and execution of IQ, OQ, and PQ test scripts.
Who You Are
- Strong GxP computer systems validation and compliance experience.
- In-depth knowledge of GxP regulations and CSV/CSA (21 CFR Part 11, Annex 11, GAMP 5, Data Integrity).
- Experience with Quality Risk Management (ICH Q9).
- 5+ years in GxP CSV roles.
- Validation/qualification knowledge in pharmaceutical quality systems.
- Strong technical writing and compliance reporting skills.
- Excellent oral and written communication across organizational levels.
Application Instructions
- Apply today.
- Lead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative.
- Ensure adherence to client requirements, regulatory compliance, and project timelines.
- Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations.
- Develop validation strategies and author validation documents (validation master plans, data migration plans, protocols, reports, discrepancy resolutions).
- Manage and optimize validation testing processes using risk-based approaches aligned with FDA Computer Software Assurance (CSA) principles and GAMP5.
- Standardize and enhance CSV framework templates and procedures.
- Support risk management (risk-based assessments and gap remediation).
- Ensure compliance and maintain the validated state of all GxP systems.
- Manage external CSV consultants.
- Serve as SME for Data Integrity, CSV lifecycle management, and global regulatory compliance.
- Own CSV-related deviations and CAPAs.
- Partner with IT on backup/restore, disaster recovery, data retention schedules, and infrastructure qualification.
- Assist business/technical owners with requirements/specifications for GxP computerized systems.
- Oversee authoring and execution of IQ, OQ, and PQ test scripts.
Who You Are
- Strong GxP computer systems validation and compliance experience.
- In-depth knowledge of GxP regulations and CSV/CSA (21 CFR Part 11, Annex 11, GAMP 5, Data Integrity).
- Experience with Quality Risk Management (ICH Q9).
- 5+ years in GxP CSV roles.
- Validation/qualification knowledge in pharmaceutical quality systems.
- Strong technical writing and compliance reporting skills.
- Excellent oral and written communication across organizational levels.
Application Instructions
- Apply today.