• Job Description

  Req#: 25-222967
  Role: MES Engineer
  Location: Summit, NJ 07901
  Duration: 06 months
  
  Must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick.
  
  Must 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
  
  Job Description:
  About the Role
  • 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.
  
  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.
  
  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.
  
  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

• About the company

  Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

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