Our client, a leading pharmaceutical company, is hiring a MES Engineer, on a contract basis.
Job ID #: 82365
Work Location:
New Brunswick, NJ – 50% on site
Summary:
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. Youll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions.
Education/Experience:
- Bachelors degree in Computer Science, Information Systems, or a related engineering discipline.
- 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
Knowledge/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.
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.
Pay: $58-$60/hr