IT CSV Engineer

Evotec

IT CSV Engineer responsible for validation of GxP systems in pharmaceutical technology. Leading initiatives and collaborating with cross-functional teams to ensure regulatory compliance and efficiency.

Posted 5/16/2026full-timeRemote • Washington • 🇺🇸 United StatesMid-LevelSenior💰 $115,000 - $135,000 per yearWebsite

About the role

Key responsibilities & impact

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 such as validation master plans, data migration plans, protocols, reports, and discrepancy resolutions.
Manage and optimize validation testing processes, ensuring risk-based validation approaches align with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices.
Standardize and enhance CSV framework templates and procedures to drive continuous improvement initiatives.
Support and oversee risk management activities, including risk-based assessments and gap remediation efforts.
Ensure compliance and maintain the validated state of all GxP systems.
Manage external CSV consultants and oversee their contributions to CSV projects.
Serve as a subject matter expert (SME) for Data Integrity, CSV lifecycle management, and compliance with global regulatory expectations.
Own CSV-related deviations and CAPAs, managing remediation efforts related to CSV and Data Integrity.
Partner with IT to establish backup/restore protocols, disaster recovery strategies, adherence to data retention schedules, and infrastructure qualification requirements.
Assist business and technical owners in developing requirements and specifications for computerized systems used in GxP operations.
Oversee the authoring and execution of IQ, OQ, and PQ test scripts.

Requirements

What you’ll need

Strong experience with GxP computer systems validation and compliance.
In-depth knowledge of GxP regulations and CSV/CSA principles, including but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
Experience with Quality Risk Management (ICH Q9) and its application in CSV.
5+ years of experience in GxP CSV roles.
Thorough understanding of validation/qualification concepts within pharmaceutical quality systems.
Strong technical writing skills for validation documentation and compliance reporting.
Excellent communication skills (both oral and written) with the ability to effectively interact across organizational levels and functions.

Benefits

Comp & perks

discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
short-term and long-term disability
company paid basic life insurance
401k company match
flexible work
generous paid time off and paid holiday
wellness and transportation benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Computer System Validation (CSV)validation master plansdata migration plansprotocolsreportsdiscrepancy resolutionsrisk-based validationIQ, OQ, PQ test scriptsQuality Risk Management (ICH Q9)Data Integrity

Soft Skills

technical writingcommunicationcollaborationproject managementleadershipproblem-solvingorganizational skillsinterpersonal skillscontinuous improvementsubject matter expertise