Summary:
The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle management of computerized systems within a regulated pharmaceutical/biotechnology manufacturing environment. The role will ensure systems are implemented, maintained, and operated in compliance with applicable GxP requirements, company procedures, data integrity principles, and regulatory expectations.
Scope of Work / Key Responsibilities:
- Develop, review, execute, and approve Computer System Validation (CSV) lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Risk Assessments, Functional/Configuration Specifications, Traceability Matrices, IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports.
- Support validation and qualification of computerized systems used in manufacturing, laboratory, quality, engineering, and automation environments.
- Perform risk-based validation activities in accordance with GAMP 5 principles and applicable regulatory requirements.
- Ensure computerized systems comply with 21 CFR Part 11, data integrity, ALCOA+ principles, and applicable GxP requirements.
- Execute and document system testing, including functional, interface, integration, security, and data integrity verification.
- Support validation of systems such as MES, ERP, DCS/DeltaV, PLC/HMI/SCADA, laboratory systems, electronic document management systems, and other GxP computerized applications.
- Review system configurations, specifications, and technical documentation to ensure compliance with approved requirements.
- Support system implementation, upgrades, changes, migrations, and decommissioning activities throughout the computerized system lifecycle.
- Participate in change controls, deviations, CAPAs, investigations, and remediation activities related to computerized systems.
- Collaborate with Quality Assurance, IT, Automation, Engineering, Manufacturing, and system owners to ensure validation requirements are incorporated into project execution.
- Maintain complete, accurate, traceable, and audit-ready validation documentation.
- Provide support during internal, client, and regulatory audits as required.
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Required Qualifications:
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, Chemistry, or a related technical discipline.
- 5+ years of experience in Computer System Validation, validation, or quality within a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment.
- Strong knowledge of the computerized system validation lifecycle and risk-based validation methodologies.
- Working knowledge of GAMP 5, 21 CFR Part 11, GxP requirements, data integrity, and ALCOA+ principles.
- Experience developing and executing validation documentation such as URS, Risk Assessments, IQ/OQ/PQ, test scripts, RTMs, and final reports.
- Experience with manufacturing, laboratory, quality, or automation computerized systems.
- Strong technical writing, documentation, analytical, and problem-solving skills.
- Ability to work effectively with cross-functional teams in a regulated project environment.
Preferred Qualifications:
- Experience within biotechnology or pharmaceutical manufacturing.
- Experience with systems such as MES, SAP/ERP, DeltaV, PLC/HMI/SCADA, LIMS, EDMS, or other GxP applications.
- Experience supporting new facility, expansion, or system implementation projects.
- Familiarity with system integration, data migration, electronic records/electronic signatures, and data integrity assessments.
- Experience supporting regulatory inspections or validation remediation projects.
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Job Details:
Contract Duration: 6+ months
Pay Range: $60.00 – $80.00 (hourly) / Additional monthly stipend if relocated
Location: On Site (Texas, USA)
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Why Apply?
This is a unique opportunity to work on a high-impact project in the pharmaceutical sector with a respected and growing firm. At SoltechPR, we value our people and are committed to offering meaningful work, professional development, and a supportive team environment. If you’re ready to bring your expertise to a major construction initiative in the regulated industry, we’d love to hear from you.
Apply today and become part of something impactful!