Computer System Validation (CSV) Specialist / Engineer – Contract Worker (Texas, USA)

Soltech PR; Town of Texas, Northern (WI, KY); Hybrid; USD 83,000 - 110,000; Full time

Benefits offered by this job

Relocation stipend

Job summary

Soltech PR is seeking a CSV Specialist/Engineer to support validation and lifecycle management of computerized systems in a regulated pharma/biotech setting. You will ensure systems are implemented, maintained, and operated in compliance with GxP, data integrity, and regulatory expectations.

Responsibilities include drafting and approving validation docs, executing testing, and ensuring systems like MES/ERP/DCS meet requirements. Collaboration with QA, IT, and Manufacturing is essential.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, Chemistry, or related technical field.
• 5+ years of experience in Computer System Validation within FDA-regulated environment.
• Knowledge of the CSV lifecycle and risk-based validation methodologies.
• Experience with 21 CFR Part 11, ALCOA+ and data integrity principles.
• Ability to develop and execute 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.

Responsibilities

• Develop, review, execute, and approve CSV lifecycle documentation (URS, IQ/OQ/PQ, validation plans, test scripts, etc.).
• Validate computerized systems across manufacturing, lab, quality, and automation environments.
• Perform risk-based validation per GAMP 5 and regulatory requirements.
• Ensure compliance with 21 CFR Part 11, data integrity and ALCOA+.
• Document testing (functional, interface, integration, security, data integrity).
• Validate systems like MES, ERP, DCS/DeltaV, PLC/HMI/SCADA, LIMS, EDMS, and other GxP apps.
• Review configurations and technical docs for compliance.
• Support system lifecycle activities: implementations, upgrades, migrations, decommissions.
• Participate in change controls, deviations, CAPAs, investigations, and remediation.
• Collaborate with QA, IT, Automation, Engineering, Manufacturing to embed validation in projects.

Skills

Technical writing

Analytical skills

Problem-solving

Cross-functional collaboration

GxP knowledge

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, Chemistry

Tools

URs/RTMs documentation tools

IQ/OQ/PQ testing tools

LIMS

EDMS

Job description

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.

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.

Job Details:

Contract Duration: 6+ months

Pay Range: $60.00 - $80.00 (hourly) / Additional monthly stipend if relocated

Location: On Site (Texas, USA)

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.