Computer Validation Specialist - Pharma Industry

ALGOBRAINZ; Plantation (FL); On-site; USD 110,000 - 140,000; Full time

Job summary

ALGOBRAINZ in Plantation, Florida is seeking a Computer Validation Specialist to ensure computerized systems stay compliant with regulatory standards. You will plan, execute, review, and maintain validation activities across software, hardware, and integrations in regulated environments.

You will work with IT, QA, Engineering, R&D, Manufacturing, and Laboratory teams to keep systems validated throughout their lifecycle and support inspection readiness and risk-based validation efforts.

Qualifications

• 4+ years of SDLC/CSV experience in a regulated industry.
• 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 lab/manufacturing systems is a plus.
• Strong communication, technical writing, organizational, and problem-solving skills.

Responsibilities

• Plan, develop, execute, and review CSV deliverables including validation plans, IQ/OQ/PQ protocols, and VSRs.
• Review validation documentation for laboratory, manufacturing, and business systems.
• Ensure compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and data integrity requirements.
• Perform risk-based validation and system integration testing to ensure data integrity and security.
• Test system interfaces with TrackWise, Empower, SAP, and other systems.
• Coordinate validation activities with IT, QA, Engineering, R&D, and vendors to meet timelines.
• Provide CSV guidance across the full system lifecycle and support validation of various applications.
• Maintain validated state throughout the SDLC and operational lifecycle.
• Support inspection readiness and respond to validation deviations.

Skills

CSV validation

Regulatory compliance

GxP

Risk-based testing

Technical writing

Tools

Empower

TrackWise

SAP

PLCs

Job description

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.

• 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.