Computer Software Validation Specialist

Syner-G • San Diego, CA

23h • $120,000 - $160,000 • Remote

About The Position

The Computer Software Validation Specialist is responsible for ensuring that GxP‑regulated software systems comply with FDA 21 CFR Part 11, cGMP, Annex 11, and GAMP 5 while also supporting business process and technology transformation initiatives. This role combines hands‑on computer software validation, documentation, and testing with business analysis, requirements gathering, data architecture support, and cross-functional solution delivery. The ideal candidate has strong technical expertise, deep knowledge of biotech and pharmaceutical business processes, and experience implementing software solutions in regulated environments. CSV experience is absolutely required, with extensive experience in software implementation, testing, and data/architecture workflows strongly preferred.

Requirements

• Education: Bachelor’s degree in Computer Science, Information Technology, Engineering, Biology, or related field; or equivalent experience.
• Experience: 2–5+ years of experience in CSV, validation, or quality assurance roles within regulated industries.
• 2–6 years as a technical Business Analyst supporting technology transformation.
• Experience implementing software in GxP environments is required.
• Clinical Trial Management Systems (CTMS) experience is required.
• Familiarity with LIMS, CDS, and related scientific or operational systems; strong understanding of the full SDLC; experience with software implementation, testing, and configuration in regulated settings.
• Technical Knowledge, Skills, Abilities: Strong analytical, technical writing, and problem-solving abilities; high attention to detail; ability to collaborate cross-functionally; strong communication and stakeholder engagement skills; proficiency with MS Office and MS Visio.
• Compliance experience is a major plus.
• CSV experience is absolutely required.
• Heavy software implementation experience and data architecture exposure are strongly preferred.

Responsibilities

• Author, review, and approve validation master plans, User Requirements Specifications (URS), Functional Specifications, configuration documents, traceability matrices, and validation summary reports.
• Testing Execution: Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols to ensure systems function as intended.
• Regulatory Compliance: Ensure systems adhere to cGMP, 21 CFR Part 11, Annex 11, and GAMP 5 while maintaining high standards for data integrity.
• Perform risk and impact assessments to determine the appropriate scope of validation for new systems, upgrades, and changes.
• Change Control and Deviations: Manage change control for validated systems, documenting deviations and driving CAPAs to closure.
• Auditing and Support: Act as a subject matter expert during internal and external audits and inspections.
• Collaborate with business users to understand objectives, requirements, and operational needs across key business areas.
• Document business requirements, functional specifications, solution designs, system requirements, and process/data flows.
• Prepare and lead coordination meetings between developers, business stakeholders, and vendors.
• Partner with developers and technical teams to clarify requirements, ensuring solutions meet approved business needs.
• Perform unit and functional testing as needed and coordinate UAT activities.
• Validate that final solutions meet documented requirements.
• Maintain and manage issue logs; ensure timely prioritization and resolution of critical issues.
• Apply information systems development, implementation, and control practices across various technology environments.
• Stay current on relevant technology trends, best practices, and industry developments.
• Contribute to data flow mapping, system interfaces, and architecture discussions for scalable, compliant system design.

Benefits

• We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars.
• This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
• Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level