CSV Engineer

Role Overview

We are seeking an experienced Computer System Validation (CSV) Engineer to support validation,

change control and lifecycle management activities for manufacturing and automation systems at our

client site at Kankakee, IL facility. This role involves development and execution of validation

deliverables for new and existing GMP computerized systems in compliance with FDA, EU Annex 11,

GAMP 5, and internal Corporate Quality Standards. This position requires onsite presence

(Monday Friday) to closely collaborate with Operations, Engineering, Automation, Quality, and IT

stakeholders.

Key Responsibilities

CSV Planning, Commissioning & Validation

Develop and execute validation strategies for new, upgraded, and existing manufacturing

systems.

Author validation plans, risk assessments, URS, functional/design specifications, and testing

protocols (IQ/OQ/PQ).

Create validation summary reports, traceability matrices, and approval documentation.

Participate in FAT/SAT, commissioning handover, field verification, and readiness assessments.

Validation Execution & Documentation

Execute IQ/OQ/PQ test scripts including documentation of evidence, screenshots, and test data.

Ensure validated systems meet data integrity and regulatory requirements (21 CFR Part 11).

Support configuration testing, access control verification, audit trail functionality assessment,

and backup/restore testing.

Change Control Support

Support the creation, review, and execution of change controls impacting validated

manufacturing systems.

Provide CSV impact assessments for software patches, hardware upgrades, configuration

changes, and vendor enhancements.

Define testing scope based on risk, design impacts, and system applicability.

Ensure all changes follow established lifecycle documentation including revision of validation

deliverables.

Work closely with QA and Engineering teams to ensure timely change closure, documentation

completeness, and traceability.

Periodic Reviews & Ongoing Lifecycle Management

Perform periodic reviews of computerized systems ensuring:
o Validation status remains current

o Configuration baselines are maintained

o Backup and restore procedures are active and verified

o Access management and security controls are in compliance

o Audit trail events are reviewed and maintained

o Preventive maintenance and calibration schedules are current

Generate periodic review reports and coordinate findings with system owners and QA.

Support remediation activities arising from periodic review gaps.

Manufacturing Systems Coverage

The scope of systems includes but is not limited to:
PLC/SCADA-based controlled equipment such as Allen Bradley

MES-connected manufacturing devices such as PasX

Distributed Control Systems (DCS) such as Factory Talk View SE

Utilities & critical process systems such as:
o WFI, Purified Water, CIP/SIP systems

o Clean Steam generator controls

o Environmental monitoring systems

Electronic batch or process reporting tools

Data historian applications such as OSI-PI

Compliance, QA Interaction & Regulatory Support

Ensure that system validation documentation complies with internal procedures and regulatory

expectations.

Participate in internal audits, walkthroughs, and inspection readiness activities.

Support deviation investigations and CAPA implementation related to computerized systems.

Skills & Qualifications

Required

Bachelor's degree in Engineering, IT, Automation, Biotechnology, or related field.

5+ years of CSV experience in GMP manufacturing environments.

Hands-on experience with validation of automation systems (PLC/SCADA/DCS).

Proven experience supporting change control execution and validation impact assessments.

Knowledge of Data Integrity guidelines and GAMP 5.