高级计算机系统验证（CSV）工程师

Company Overview
At Bridgenext, we engineer Growth Operating Systems. Most enterprises have spent millions on their revenue stack and still aren't seeing the growth they expected.They have tools that function, but no system that wins. We help growth-hungry companies close that gap by turning fragmented platforms, siloed teams, and disconnected data into one integrated Growth OS. More than a technology company or marketing agency, we're a global digital consultancy with experts in engineering, data, AI, creative and more.
Our teams are made up of experts who believe in engineering impact, starting with putting people at the center of everything we do. Every team member directly shapes our work, culture, and values. Nothing matters more to us than a kind, respectful, fulfilling environment that supports everyone. Our flexible, inclusive culture gives you the autonomy, resources, and opportunities to thrive.
Position Description
We are seeking an experienced CSV Validation Engineer to support validation, compliance, and quality management activities in a GxP-regulated environment. Key deliverables are preparation of relevant documentation (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices) to meet regulatory requirements for new and existing products. You will collaborate with cross functional teams, ensuring compliance with regulatory requirements, and drives best-in-class validation practices that support our applications and operational excellence.
Key Responsibilities:

• Lead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GxP software applications

• Assess the impact of system-related events on the system’s validated state and data reliability

• Lead validation execution and ensure testing is appropriately documented

• Support change control, system upgrades, migrations, releases, and impact assessments

• Support the execution and generation of formal risk assessments

• Support and conduct periodic reviews

• Support the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival

• Support risk-based Data Integrity Assessments and the audit trail review process

• Provide CSV and Data Integrity expertise during vendor selection and qualification. Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention

• Provide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirements

• Hands-on experience with Jira for test management, defect tracking, requirements traceability, and project coordination

• Collaborate with business, quality, IT, and regulatory stakeholders to ensure ongoing compliance with applicable requirements

Workplace: Remote based role in LATAM, preferably in Argentina
Must Have Skills:

• Bachelor’s degree in computer science, Information Technology, or a related field (or equivalent experience)

• 5+ years of Computer System Validation (CSV) experience

• Strong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems

• Demonstrated experience developing and executing risk-based CSV strategies

• Experience with computerized system periodic reviews

• Experience with audit trail and data integrity assessments

• Ability to report on project activity in a clear and concise manner

• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization

• Strong technical writing skills

• Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat

• Strong project management skills with the ability tmanage multiple activities with challenging timelines

• Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines

Professional Skills:

• Excellent English communication (written and oral)

• Excellent analytical and problem-solving skills

• Ability to work effectively in a fast-paced, dynamic environment

• Strong interpersonal skills

• Ability to understand scope and ask the right questions

• Organized, detail and process oriented

• Proven ability to build, manage and foster a team-oriented environment

Bridgenext is an Equal Opportunity Employer
Originally posted on Himalayas