IT CSV Engineer (Remote)
Evotec
21 days ago
Remote friendly (Redmond, WA)
United States
IT
Responsibilities:
- Lead validation efforts for MFG, QC, enterprise, and PP&D systems within the Sandoz remediation initiative.
- Ensure adherence to client requirements, regulatory compliance, and project timelines.
- Collaborate cross-functionally to execute complex Computer System Validation (CSV) projects (remediation and new implementations).
- Develop validation strategies and author documents (validation master plans, data migration plans, protocols, reports, discrepancy resolutions).
- Manage/optimize validation testing using risk-based approaches aligned with FDA Computer Software Assurance (CSA) and GAMP 5.
- Standardize/enhance CSV templates and procedures.
- Support risk management (risk-based assessments and gap remediation).
- Maintain compliance and the validated state of all GxP systems.
- Manage external CSV consultants.
- Serve as SME for Data Integrity, CSV lifecycle management, and global regulatory expectations.
- Own CSV-related deviations and CAPAs; manage CSV/Data Integrity remediation.
- Partner with IT on backup/restore, disaster recovery, data retention adherence, and infrastructure qualification.
- Assist business/technical owners with requirements/specifications for GxP computerized systems.
- Oversee authoring/execution of IQ, OQ, and PQ test scripts.
Qualifications/Skills:
- 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 applying ICH Q9 Quality Risk Management in CSV.
- 5+ years in GxP CSV roles.
- Thorough validation/qualification understanding in pharmaceutical quality systems.
- Strong technical writing and oral/written communication across organizational levels.
Benefits:
- Base pay range: $115,000–$135,000; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; company-paid basic life insurance; 401(k) match; flexible work; paid time off/paid holidays; wellness and transportation benefits.
Application Instructions:
- Apply today.
- Lead validation efforts for MFG, QC, enterprise, and PP&D systems within the Sandoz remediation initiative.
- Ensure adherence to client requirements, regulatory compliance, and project timelines.
- Collaborate cross-functionally to execute complex Computer System Validation (CSV) projects (remediation and new implementations).
- Develop validation strategies and author documents (validation master plans, data migration plans, protocols, reports, discrepancy resolutions).
- Manage/optimize validation testing using risk-based approaches aligned with FDA Computer Software Assurance (CSA) and GAMP 5.
- Standardize/enhance CSV templates and procedures.
- Support risk management (risk-based assessments and gap remediation).
- Maintain compliance and the validated state of all GxP systems.
- Manage external CSV consultants.
- Serve as SME for Data Integrity, CSV lifecycle management, and global regulatory expectations.
- Own CSV-related deviations and CAPAs; manage CSV/Data Integrity remediation.
- Partner with IT on backup/restore, disaster recovery, data retention adherence, and infrastructure qualification.
- Assist business/technical owners with requirements/specifications for GxP computerized systems.
- Oversee authoring/execution of IQ, OQ, and PQ test scripts.
Qualifications/Skills:
- 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 applying ICH Q9 Quality Risk Management in CSV.
- 5+ years in GxP CSV roles.
- Thorough validation/qualification understanding in pharmaceutical quality systems.
- Strong technical writing and oral/written communication across organizational levels.
Benefits:
- Base pay range: $115,000–$135,000; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; company-paid basic life insurance; 401(k) match; flexible work; paid time off/paid holidays; wellness and transportation benefits.
Application Instructions:
- Apply today.