Software Validation Specialist

Somewhere; United States; Remote; USD 120,000 - 170,000; Part time

Job summary

Somewhere is seeking a Software Validation Specialist to plan, execute, and document commissioning, qualification, and CSV activities across GxP systems, laboratory and manufacturing environments. This role operates in a regulated environment, ensuring systems and software remain validated and compliant with 21 CFR Part 11 and data integrity standards.

You will work independently and with SMEs, QA, IT, and manufacturing teams to develop validation requirements, author audit-ready documentation,

Qualifications

• Bachelor’s degree in engineering, computer science, life sciences, or related technical discipline.
• 5+ years of experience in equipment qualification and validation in pharma/biopharma/medical devices.
• 3+ years of hands-on experience in Computer System Validation (CSV).
• Experience validating GAMP Category 4 (configured) and Category 5 (custom) software using GAMP 5 principles.

Responsibilities

• Develop validation strategies aligned with ISPE Baseline Guide (C&Q, 2nd Edition), FDA expectations, and internal policies.
• Contribute to Validation Master Plans (VMPs), project validation plans, SOPs, and lifecycle documentation.
• Participate in system impact assessments and classification of equipment and computerized systems.
• Plan, author, review, and execute CSV activities for GxP systems including IQ/OQ/PQ and traceability.
• Develop and maintain lifecycle documentation (Validation Plans, Risk Assessments, protocols).
• Ensure audit-ready qualification and CSV documentation and manage deviations and change control.

Skills

Regulatory knowledge

Problem solving

Project management

Test automation / CSV tools

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline

Job description

• Vendor Management: Leverage vendor documentation appropriately to support internal qualification activities.

Engagement Type

Independent Contractor Agreement (100% Remote)

Department

Quality Assurance / IT Validation

Position Overview

The Software Validation Specialist is responsible for planning, executing, and documenting commissioning, qualification, and Computer System Validation (CSV) activities across GxP computerized systems, laboratory systems, manufacturing equipment, utilities, facilities, and processes. Operating within a regulated GxP environment, this role ensures all systems, software, and equipment are fit for their intended use, compliant with applicable regulatory requirements (including 21 CFR Part 11 and data integrity standards), and maintained in a validated state throughout their lifecycle. The specialist works both independently and collaboratively with cross-functional Subject Matter Experts (SMEs), Quality Assurance, IT, Engineering, Manufacturing, Laboratory, and Facilities teams to define validation requirements, establish acceptance criteria, author audit‑ready documentation, and resolve deviations.

Roles And Responsibilities

• Equipment Qualification & Strategy Alignment
• Validation Strategy: Support the development and implementation of validation strategies aligned with ISPE Baseline Guide (C&Q, 2nd Edition), FDA expectations, and internal policies and procedures.
• System Impact & Classification: Participate in system impact assessments and the classification of equipment and computerized systems.
• Master Planning: Contribute to and maintain Validation Master Plans (VMPs), project validation plans, process flow diagrams, and standard operating procedures (SOPs).
• Risk-Based Execution: Apply risk-based principles to all qualification and lifecycle activities.
• Qualification & Life Cycle Activities
• Protocol & Lifecycle Documentation: Develop, review, and execute validation and qualification documentation, including:
  • User Requirement Specifications (URS) / System Requirement Specifications (SRS) support
  • Design Review (DR) and Design Qualification (DQ)
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Traceability Matrices and Qualification Summary Reports
• Vendor Management: Leverage vendor documentation appropriately to support internal qualification activities.
• Computerized Systems & Software Validation (CSV)
• CSV Execution: Plan, author, review, and execute Computer System Validation activities for GxP computerized systems, including standalone applications, configured/customized systems (GAMP Category 4 & 5), laboratory software, equipment controls, and interfaces.
• Risk-Based CSV Lifecycle: Develop and maintain lifecycle documentation such as Validation Plans, Functional/Configuration Specifications, Risk Assessments, IQ/OQ/PQ protocols, test scripts, Requirements Traceability Matrices, and Periodic Reviews.
• Regulatory & Compliance Assurance: Ensure software systems comply with relevant industry standards and regulations, including GAMP 5, 21 CFR Part 11, and Annex 11 (Electronic Records / Electronic Signatures).
• Technical Controls Assessment: Evaluate system functionality related to user access controls, security, audit trails, electronic signatures, data retention, backup/recovery, and backup integrity.
• Data Integrity (ALCOA+): Ensure all computerized and qualified systems support data integrity principles across the data lifecycle.
• Compliance, Documentation & Change Management
• Audit‑Ready Documentation: Ensure qualification and CSV documentation is complete, accurate, technically sound, and fully compliant with GxP standards.
• Deviation Management: Investigate, document, and manage deviations or non‑conformances arising during validation activities.
• Change Control: Manage software and equipment change control processes, assessing the impact of changes on the validated state and conducting requalification activities as required.

Minimum Qualifications & Requirements

Education

• Bachelor’s Degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.

Experience

• General Validation: Minimum of 5 years of experience in equipment qualification and validation within the pharmaceutical, biopharmaceutical, or medical device industries.
• Computer System Validation: Minimum of 3 years of hands‑on experience in Computer System Validation (CSV).
• Scope of Experience: Proven track record in qualification and validation covering GxP computerized systems, laboratory equipment, manufacturing equipment, utilities, cleaning processes, and temperature mapping.
• GAMP 5: Demonstrated experience validating GAMP Category 4 (configured) and Category 5 (custom) software systems using GAMP 5 principles.
• Technical Writing: Exceptional technical writing skills with a track record of producing clear, audit‑ready validation packages.

Specific Skills & Competencies

• Regulatory Knowledge: Deep understanding of GAMP 5 principles, ISPE C&Q lifecycle approaches, 21 CFR Part 11, and ALCOA+ data integrity framework.
• Problem Solving: Strong analytical thinking and problem‑solving skills to manage complex technical issues and equipment deviations.
• Project Management: Excellent organization and project management skills with the ability to balance multiple deadlines and stakeholders simultaneously.
• Test Automation / CSV Tools: Familiarity or experience with automated testing frameworks and CSV methodologies.

Working Conditions & Contractor Engagement

• Engagement Type: Independent Contractor Agreement.
• Location: 100% Remote / Virtual.
• Collaboration: Requires proactive collaboration across cross‑functional remote teams and time zones.