IT CSV Engineer
Evotec
August 20, 2026
Remote friendly (Redmond, WA)
United States
IT
Responsibilities:
- 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 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 validation aligned with FDA Computer Software Assurance (CSA) and GAMP 5.
- Standardize and enhance CSV framework templates and procedures.
- Support risk management activities (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 expectations.
- Own CSV-related deviations and CAPAs; manage remediation for CSV and Data Integrity.
- Partner with IT for backup/restore, disaster recovery, data retention, and infrastructure qualification.
- Assist business/technical owners with requirements and specifications for GxP computerized systems.
- Oversee authoring/execution of IQ, OQ, and PQ test scripts.
Qualifications/Skills:
- Strong experience in GxP computer systems validation and compliance.
- In-depth knowledge of GxP regulations and CSV/CSA principles (21 CFR Part 11, Annex 11, GAMP 5, Data Integrity).
- Experience with Quality Risk Management (ICH Q9) in CSV.
- 5+ years of experience in GxP CSV roles.
- Strong understanding of validation/qualification in pharmaceutical quality systems.
- Strong technical writing and communication skills.
Benefits:
- Base pay range: $115,000–$135,000; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; company-paid basic life insurance; 401k match; flexible work; generous paid time off and paid holidays; wellness and transportation benefits.
Application:
- 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 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 validation aligned with FDA Computer Software Assurance (CSA) and GAMP 5.
- Standardize and enhance CSV framework templates and procedures.
- Support risk management activities (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 expectations.
- Own CSV-related deviations and CAPAs; manage remediation for CSV and Data Integrity.
- Partner with IT for backup/restore, disaster recovery, data retention, and infrastructure qualification.
- Assist business/technical owners with requirements and specifications for GxP computerized systems.
- Oversee authoring/execution of IQ, OQ, and PQ test scripts.
Qualifications/Skills:
- Strong experience in GxP computer systems validation and compliance.
- In-depth knowledge of GxP regulations and CSV/CSA principles (21 CFR Part 11, Annex 11, GAMP 5, Data Integrity).
- Experience with Quality Risk Management (ICH Q9) in CSV.
- 5+ years of experience in GxP CSV roles.
- Strong understanding of validation/qualification in pharmaceutical quality systems.
- Strong technical writing and communication skills.
Benefits:
- Base pay range: $115,000–$135,000; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; company-paid basic life insurance; 401k match; flexible work; generous paid time off and paid holidays; wellness and transportation benefits.
Application:
- Apply today.