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Validation Engineer - Systech Systems
Validation Engineer - Systech SystemsAutomated Systems, Inc. (ASI) • Round Lake, IL, US
Validation Engineer - Systech Systems

Validation Engineer - Systech Systems

Automated Systems, Inc. (ASI) • Round Lake, IL, US
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Validation Engineer – Systech Systems

Location : Round Lake, IL

Contract : 12-Month Contract with strong possibility of extensions

Schedule : Full-time, Monday–Friday (some off-hours support possible during line trials and validations)

Our client is seeking an experienced Validation Engineer with specific expertise in Systech serialization and vision inspection systems. The selected candidate will support validation, qualification, and change control activities associated with packaging line serialization equipment and related data management systems at their Round Lake facility. This role ensures that all Systech systems remain compliant with FDA, EU, and global serialization regulations, and that validation deliverables align with the client's corporate quality and computer system validation (CSV) standards.

Key Responsibilities :

  • Develop and execute validation protocols (IQ / OQ / PQ) for Systech serialization systems, vision inspection systems, and associated packaging line controls.
  • Author, review, and approve Validation Plans, Test Scripts, and Summary Reports in alignment with Baxter's global validation and data integrity policies.
  • Perform change control impact assessments, manage system configuration documentation, and ensure traceability from user requirements through testing and release.
  • Collaborate with Automation, IT, Quality, and Packaging Engineering teams to ensure proper integration between Level 2–3 systems (line to site) and enterprise-level (Level 4) traceability systems.
  • Support troubleshooting and revalidation following system upgrades, software patches, or hardware replacements.
  • Participate in audits, inspections, and CAPA investigations, providing validation support and documentation as needed.
  • Maintain validation documentation in compliance with 21 CFR Part 11, GAMP 5, and Annex 11 expectations.
  • Contribute to continuous improvement of validation templates, testing standards, and risk-based validation strategies.

Education, Experience & Skill Qualifications :

  • Bachelor's degree in Engineering, Computer Science, or Life Sciences.
  • Minimum 5 years of experience in validation of automated systems in the pharmaceutical or medical device industry.
  • Demonstrated experience with Systech serialization platforms (Inspector, Advisor, Serialized Global Tracking, or similar).
  • Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles.
  • Familiarity with packaging line controls, PLCs, and vision inspection systems (Cognex, Keyence, or equivalent).
  • Excellent technical writing and documentation skills.
  • Ability to work cross-functionally within a fast-paced GMP manufacturing environment.

    • Additional Details :

  • Reports to : Validation Manager or CSV Lead
  • Work Environment : On-site in a GMP-controlled packaging and validation laboratory setting
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    Validation Engineer • Round Lake, IL, US