Job 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.
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 udit 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.
Requirements: - 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.
- 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.
- Must Have 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.