Overview
HybridCandidates must be onsite 50% of the time
$55 - $60
Contract - W2
Contract - 6 Month(s)
No Travel Required
Skills
Document Management
Computer Science
Application Lifecycle Management
GAMP
Global Positioning System
Data Integrity
Database
Documentation
FOCUS
CMMS
Computerized System Validation
GDP
LIMS
MES
Management
Manufacturing Execution System
Master Data Management
Good Manufacturing Practice
Information Systems
Interfaces
Issue Tracking
OQ
Oracle
Pharmaceutics
Process Automation
Project Management
Quality Assurance
Risk Assessment
SAP
SQL
Scripting
ServiceNow
Software Development Methodology
System Testing
Test Execution
Auditing
Test Plans
Acceptance Testing
Test Scripts
Testing
URS
Veeva
Job Details
Job Title: MES Engineer Job ID: 25-07988 Location: Summit, NJ Duration: 06 Month s Contract on W2
Candidates must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick.
Must Have List
Candidates 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, Docs), supporting testing, issue tracking, and controlled documentation.
- Holds a Bachelor s degree in Computer Science or a related technical discipline
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
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 fastpaced, crossfunctional 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
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