Software Validation Specialist

Engagement Type: Independent Contractor Agreement (100% Remote)

Department: Quality Assurance / IT Validation

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.

• 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.

• 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.

• 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.

• 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.

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

• 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.

• 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.

• Engagement Type: Independent Contractor Agreement.

• Location: 100% Remote / Virtual.

• Collaboration: Requires proactive collaboration across cross-functional remote teams and time zones.