Mes Engineer

Description:

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.

o Key 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.

o Required Competencies

-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.

o Basic Qualifications

-Bachelor’s degree in computer science, Information Systems, or a related engineering discipline.

-Minimum 3 years of experience in pharma/biotech, with focus on IT -Validation and Quality Assurance & Compliance

-Experience with MES platforms (Syncade preferred) and electronic batch records (EBR).

-Familiar with tools such as ALM, ServiceNow, SQL databases, and document management systems.

-Knowledge of shop floor operations, process automation, and manufacturing environments are preferable