What are the responsibilities and job description for the Computer Validation Specialist - Pharma Industry position at ALGOBRAINZ?
Title: Computer Validation Specialist - Pharma Industry
Experience : 6 years
Location: Plantation, Florida
Job Summary:
The Computer Validation Specialist will be responsible for ensuring that computerized systems remain compliant with applicable regulatory requirements, company policies, and established quality procedures. This role will support the planning, execution, review, and maintenance of validation activities for computerized systems, software, hardware, and system integrations across regulated environments. The individual will work closely with IT, Quality, Engineering, R&D, Manufacturing, Laboratory, and other business teams to ensure systems are implemented, tested, documented, and maintained in a validated and controlled state throughout their lifecycle.
Roles & Responsibilities:
- Plan, develop, execute, and review CSV deliverables, including GxP/21 CFR Part 11 assessments, Validation Plans, URS, Functional/Design Specifications, Risk Assessments, RTM, IQ/OQ/PQ protocols, test scripts, execution reports, and VSRs.
- Review validation documentation for laboratory, manufacturing, and business systems and perform retrospective validation when required.
- Ensure compliance with FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and data integrity requirements.
- Perform risk-based validation and system integration testing to ensure data integrity, security, reliability, and performance.
- Test system interfaces and integrations with TrackWise, Empower, SAP, and other laboratory, manufacturing, and enterprise systems.
- Conduct pre- and post-execution reviews of protocols, test scripts, evidence, and defects, ensuring issues are properly assessed and resolved.
- Collaborate with IT, QA, Engineering, R&D, business teams, and vendors to coordinate validation activities and meet timelines.
- Provide management with regular updates on project progress, risks, issues, dependencies, and recommended actions.
- Provide CSV guidance throughout the complete system lifecycle, including design, implementation, deployment, maintenance, upgrades, changes, and retirement.
- Support validation of in-house, contractor-developed, and commercial/off-the-shelf (OTS) applications.
- Research regulatory requirements and industry practices and recommend practical, compliant solutions to validation challenges.
- Review and approve validation documentation for compliance with CSV procedures, quality standards, and regulatory requirements.
- Coordinate with IT, QA, business teams, and vendors for protocol execution, troubleshooting, SOP development/updates, and validation deviation management.
- Apply risk-based judgment when evaluating, documenting, and resolving validation issues.
- Maintain the validated state of computerized systems throughout the SDLC and operational lifecycle.
- Ensure strong inspection readiness across the CSV portfolio and minimize compliance risks and potential inspection observations.
- Perform periodic system reviews covering validation status, performance, changes, risks, and ongoing compliance.
- Perform other duties and responsibilities as assigned.
Required Qualifications:
- 4 years of SDLC/CSV experience in a regulated industry, preferably Life Sciences.
- Strong knowledge of GAMP 5, CSV/CSA, data integrity, and FDA 21 CFR Part 11.
- Experience with manual testing, system integration, and validation documentation.
- Understanding of IT infrastructure and system qualification.
- Experience with Empower, TrackWise, SAP, PLCs, or laboratory/manufacturing systems is a plus.
- Strong communication, technical writing, organizational, and problem-solving skills.