Automation CSV Engineer in Mundelein

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• System Validation Strategy: Develop risk-based lifecycle validation strategies for automation platforms (e.g., Emerson DeltaV, SCADA, PLCs, AVEVA/OSIsoft PI, batch systems). Lead validation activities for new system implementations, upgrades, modifications, and decommissioning. \n

• Lifecycle Documentation: Author, review, and execute core validation deliverables, including Validation Plans, URS, FRS, Risk Assessments, RTMs, FAT/SAT, IQ/OQ/PQ protocols, test scripts, deviations, summary reports, and SOPs. \n

• Testing & Execution: Coordinate and execute functional, regression, and qualification testing. Verify control logic (sequences, recipes, interlocks, alarms) and objective evidence against design specifications. Troubleshoot and document discrepancies to resolution. \n

• Data Integrity & Compliance: Facilitate risk and data integrity assessments in accordance with ALCOA+ principles, 21 CFR Part 11, EU Annex 11, and GAMP 5. Maintain systems in a validated state through periodic reviews, access control reviews, and audit trail evaluations. \n

• Change Control & Quality Systems: Provide technical impact assessments for proposed hardware/software/configuration changes within formal quality systems (Change Control, Deviations, CAPAs). Support internal/external audits and regulatory inspection readiness. \n

• Cross-Functional Collaboration: Partner with internal teams and external vendors/system integrators to align technical execution with site compliance standards and project timelines. \n

• Education: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical field (or equivalent combination of education and experience). \n

• Experience: 5+ years of experience in automation system validation (CSV), commissioning and qualification, or automation quality within a regulated (GMP) environment. \n

• Technical Proficiency: Hands-on experience with industrial automation technologies such as Emerson DeltaV, AVEVA/OSIsoft PI, SCADA, PLCs, or batch systems. \n

• Compliance Knowledge: In-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity principles, and risk-based Computerized System Assurance (CSA). \n

• Core Skills: Strong technical writing, systematic documentation, problem-solving, and cross-functional communication abilities. \n

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• Direct experience validating Emerson DeltaV systems in pharmaceutical, biotech, or gene therapy manufacturing. \n

• Familiarity with MES, process historians, laboratory systems, eQMS, or building automation platforms (BAS). \n

• Experience leveraging vendor testing/documentation and supporting regulatory agency audits. \n

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Work Environment & Travel

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• Flexibility: Occasional schedule flexibility required during system cutovers, testing campaigns, and manufacturing shutdowns. \n

• Safety: Ability to work in controlled manufacturing and laboratory environments in accordance with gowning and safety rules. \n

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Why Join Us?

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• Growth & Mentorship: Access continuous learning, professional development, and career growth opportunities. \n

• Innovative Impact: Work with state-of-the-art technologies on high-impact projects. \n

• Inclusive Culture: Work in a collaborative environment where diverse perspectives and new ideas are valued. \n

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