CSV & MES Validation Specialist for Syncade

Inteldot; Northern (KY); On-site; USD 75,000 - 120,000; Full time

Job summary

Inteldot seeks an experienced Computer System Validation Specialist to support validation activities for the Syncade MES within a regulated pharmaceutical manufacturing environment. The ideal candidate will have hands-on CSV experience, GxP knowledge, and strong documentation skills to support validation, testing, and implementation.

Responsibilities include IQ/OQ/PQ testing, risk assessments, and collaboration with Manufacturing, Automation, IT, and Quality to ensure compliant validation

Qualifications

• Strong knowledge of computer system validation (CSV) principles.
• Experience in GMP/GxP-regulated environments.
• Experience developing and executing validation test scripts.
• Ability to document validation deliverables clearly and concisely.
• Familiarity with risk-based validation methodologies and change control processes.

Responsibilities

• Support validation activities for CSV and MES-like systems in a regulated setting.
• Develop, review, and execute validation documentation per procedures and regulatory requirements.
• Prepare IQ, OQ, PQ, UAT, and regression testing as applicable.
• Create and execute test scripts; document results, deviations and exceptions.
• SupportURS/FS development and mapping of user requirements to validation deliverables.
• Ensure traceability from requirements to test cases and risk assessments.

Skills

CSV concepts

GxP compliance

Manufacturing systems

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences

Job description

Inteldot seeks an experienced Computer System Validation Specialist to support validation activities for the Syncade MES within a regulated pharmaceutical manufacturing environment. The ideal candidate will have hands-on CSV experience, GxP knowledge, and strong documentation skills to support validation, testing, and implementation.

Responsibilities include IQ/OQ/PQ testing, risk assessments, and collaboration with Manufacturing, Automation, IT, and Quality to ensure compliant validation