MES Engineer

We’re seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You’ll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions.

About the Role - Lead end-to-end validation activities including test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation, and post-execution review. Develop and execute validation deliverables including URS, Risk Assessments, IQ/OQ/PQ, and Summary Reports. Ensure all activities comply with 21 CFR Part 11, GAMP 5, and internal SOPs. Author, Review and Approve validation documentation lifecycle: Validation & Test Plan, requirement, Test Scripts, Assessment documents, and Summary Reports. Validate electronic batch records (EBR), MES recipes, interfaces, and integration with systems such as SAP, Oracle, LIMS, CMMS, GPS, and EDMS. Collaborate with Business Owners, QA, and IT to align on requirements and ensure CSV deliverables are compliant and audit-ready. Coordinate recipe configuration, master data setup, and validation in Syncade MES. Ensure validation practices meet GAMP 5, CSA, 21 CFR Part 11, and ALCOA+ data integrity principles.

Responsibilities

Lead end-to-end validation activities including test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation, and post-execution review.

Develop and execute validation deliverables including URS, Risk Assessments, IQ/OQ/PQ, and Summary Reports.

Ensure all activities comply with 21 CFR Part 11, GAMP 5, and internal SOPs.

Author, Review and Approve validation documentation lifecycle: Validation & Test Plan, requirement, Test Scripts, Assessment documents, and Summary Reports.

Validate electronic batch records (EBR), MES recipes, interfaces, and integration with systems such as SAP, Oracle, LIMS, CMMS, GPS, and EDMS.

Collaborate with Business Owners, QA, and IT to align on requirements and ensure CSV deliverables are compliant and audit-ready.

Coordinate recipe configuration, master data setup, and validation in Syncade MES.

Ensure validation practices meet GAMP 5, CSA, 21 CFR Part 11, and ALCOA+ data integrity principles.

Required Skills

Proven ability to manage competing priorities with a flexible workstyle and consistently deliver efficient, compliant results in fast-paced, cross-functional environments.

Experienced in cross-functional communication, with the ability to interpret and convey business and IT need to Validation; comfortable interacting with QA, business, and technical teams.

Deep understanding of MES Syncade & Recipes testing phases (IQ, System Testing, Recipe UAT).

Familiarity with cGMP, GAMP, SDLC, 21 CFR Part 11, and Good Documentation Practices (GDP).

Demonstrated ability to independently lead system validation efforts across multiple stakeholder groups.