MES Validation Engineer

Summit, NJ BMS Office // In-person interview for 2^nd round so local only

Have List

• 4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.
• 3+ years of hands-on MES experience with Emerson Syncade, including recipe validation, EBR testing, and interface verification with systems such as SAP, LIMS, and Oracle.
• 2+ years of project management experience, demonstrating the ability to prioritize urgent tasks, manage competing deadlines, and adapt effectively within dynamic, cross-functional teams.
• 3+ years of advanced experience with ALM, ServiceNow, SQL databases, and document management systems (e.g., Veeva, BMSDocs), supporting testing, issue tracking, and controlled documentation.
• Holds a Bachelor s degree in Computer Science or a related technical discipline

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