CSV Engineer

Blackfield Associates are supporting a leading pharmaceutical manufacturer in their search for a Computer System Validation (CSV) Engineer to join their manufacturing operations team.

Responsibilities

• Execute and lead Computer System Validation (CSV) activities for Emerson Syncade MES, ensuring systems are implemented and maintained in compliance with GMP, GxP, and 21 CFR Part 11 requirements.
• Author, review, and approve validation lifecycle documentation including Validation Plans, Risk Assessments, URS, Functional Specifications, IQ, OQ, PQ protocols, traceability matrices, and Validation Summary Reports.
• Configure, validate, and support Syncade Electronic Batch Records (EBR), workflow management, recipe management, and manufacturing process execution functionalities.
• Collaborate with Manufacturing, Quality, Automation, IT, and Engineering teams to gather requirements, troubleshoot issues, and deliver compliant Syncade MES solutions.
• Manage change controls, deviations, CAPAs, and impact assessments related to Syncade implementations, upgrades, enhancements, and system integrations.
• Ensure data integrity and regulatory compliance across the Syncade platform, adhering to ALCOA+, GMP, GxP, and 21 CFR Part 11 standards while supporting audit and inspection readiness.
• Provide SME expertise for Emerson Syncade MES, supporting system deployment, qualification, continuous improvement initiatives, and integration with ERP, LIMS, and other GxP-regulated manufacturing systems.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related discipline.
• 4+ years of experience validating Emerson Syncade MES within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Strong knowledge of Computer System Validation (CSV), GxP, 21 CFR Part 11, Data Integrity, and validation lifecycle documentation (IQ/OQ/PQ).

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