GxP CSV Engineer — Validation Lifecycle Lead

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

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.