Job Overview
Location
Redmond
Job Type
Full-time
Category
Software Engineering
Date Posted
May 17, 2026
Full Job Description
đź“‹ Description
- • 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 for all Computer System Validation (CSV) activities.
- • Collaborate with cross-functional teams to execute complex CSV projects, including remediation and new system implementations.
- • Develop validation strategies and author key documentation including validation master plans, data migration plans, protocols, reports, and discrepancy resolutions.
- • Manage and optimize validation testing processes using risk-based approaches aligned with FDA Computer Software Assurance (CSA) principles and GAMP5 practices.
- • Standardize and enhance CSV framework templates and procedures to drive continuous improvement across the organization.
- • Support and oversee risk management activities, including conducting risk-based assessments and implementing gap remediation initiatives.
- • Ensure compliance and maintain the validated state of all GxP systems in accordance with global regulatory standards.
- • Manage external CSV consultants and oversee their deliverables on active validation projects.
- • Serve as a subject matter expert (SME) for Data Integrity, CSV lifecycle management, and compliance with FDA 21 CFR Part 11, Annex 11, GAMP 5, and other global regulatory expectations.
- • Own CSV-related deviations and CAPAs, leading remediation efforts related to data integrity and system validation.
- • Partner with IT to establish backup/restore protocols, disaster recovery strategies, 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 Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts.
- • Maintain documentation integrity and audit readiness for all CSV-related activities across global regulatory jurisdictions.
🎯 Requirements
- • 5+ years of experience in GxP Computer System Validation (CSV) roles
- • In-depth knowledge of GxP regulations including 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity principles
- • Experience applying Quality Risk Management (ICH Q9) to CSV activities
- • Strong technical writing skills for validation documentation and compliance reporting
- • Demonstrated ability to lead cross-functional CSV projects and manage external consultants
- • Thorough understanding of IQ, OQ, and PQ test execution and validation lifecycle management
🏖️ Benefits
- • Base salary range of $115,000 to $135,000 at commencement of employment
- • Discretionary annual bonus
- • Comprehensive benefits including Medical, Dental, and Vision coverage
- • Short-term and long-term disability insurance
- • Company-paid basic life insurance
- • 401(k) with company match
- • Flexible work arrangements
- • Generous paid time off and paid holidays
- • Wellness and transportation benefits
Skills & Technologies
See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.
About Evotec SE
Evotec SE is a drug discovery and development company that partners with pharmaceutical and biotechnology companies. They offer a wide range of services across the entire drug discovery and development continuum, from target identification and validation to preclinical and clinical development. Evotec utilizes its integrated technology platforms, including small molecule and biologics discovery, cell-based assays, and advanced analytics, to accelerate the identification and optimization of novel drug candidates. Their business model focuses on generating value through research and development collaborations, milestone payments, and royalties on successfully commercialized products. Evotec operates globally, contributing to the advancement of innovative therapies for various diseases.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
Careerswift AI Inc.
2 months ago
Notable Inc.
15 days ago
4 months ago
Ryder System, Inc.
2 months ago