Automated Systems
Validation Engineer - Systech Systems Expertise
Automated Systems, Lake Barrington, Illinois, United States
Validation Engineer - Systech Systems Expertise
Contract Duration:
12-Month Contract with strong possibility of extensions Schedule:
Full-time, Monday-Friday (some off-hours support may be needed during line trials and validations) We are actively seeking a skilled Validation Engineer specializing in Systech serialization and vision inspection systems. This role involves supporting validation, qualification, and change control activities for packaging line serialization equipment and related data management systems at our facility in Round Lake, IL. As a part of our team, you will ensure compliance with FDA, EU, and global serialization regulations, while aligning validation deliverables with 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 consistent with organizational validation and data integrity policies. Conduct change control impact assessments and manage system configuration documentation, ensuring traceability from user requirements through testing and release. Collaborate with Automation, IT, Quality, and Packaging Engineering teams to optimize integration between Level 2-3 systems (line to site) and enterprise-level (Level 4) traceability systems. Provide troubleshooting and revalidation support following system upgrades, software patches, or hardware replacements. Assist in audits, inspections, and CAPA investigations, supplying validation support and necessary documentation. Ensure validation documentation complies with 21 CFR Part 11, GAMP 5, and Annex 11 requirements. Contribute to the 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. A minimum of 5 years of experience in validating automated systems in the pharmaceutical or medical device industry. Proven experience with Systech serialization platforms (Inspector, Advisor, Serialized Global Tracking, or similar). Thorough 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). Exceptional technical writing and documentation skills. Adept at working 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
12-Month Contract with strong possibility of extensions Schedule:
Full-time, Monday-Friday (some off-hours support may be needed during line trials and validations) We are actively seeking a skilled Validation Engineer specializing in Systech serialization and vision inspection systems. This role involves supporting validation, qualification, and change control activities for packaging line serialization equipment and related data management systems at our facility in Round Lake, IL. As a part of our team, you will ensure compliance with FDA, EU, and global serialization regulations, while aligning validation deliverables with 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 consistent with organizational validation and data integrity policies. Conduct change control impact assessments and manage system configuration documentation, ensuring traceability from user requirements through testing and release. Collaborate with Automation, IT, Quality, and Packaging Engineering teams to optimize integration between Level 2-3 systems (line to site) and enterprise-level (Level 4) traceability systems. Provide troubleshooting and revalidation support following system upgrades, software patches, or hardware replacements. Assist in audits, inspections, and CAPA investigations, supplying validation support and necessary documentation. Ensure validation documentation complies with 21 CFR Part 11, GAMP 5, and Annex 11 requirements. Contribute to the 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. A minimum of 5 years of experience in validating automated systems in the pharmaceutical or medical device industry. Proven experience with Systech serialization platforms (Inspector, Advisor, Serialized Global Tracking, or similar). Thorough 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). Exceptional technical writing and documentation skills. Adept at working 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