Overview
On Site
USD 58.00 - 60.00 per hour
Contract - W2
Skills
Recruiting
SAP BASIS
Manufacturing Execution System
Computer Science
Information Systems
Pharmaceutics
FOCUS
Regulatory Compliance
Application Lifecycle Management
ServiceNow
SQL
Database
Process Automation
Manufacturing
Management
Communication
Testing
System Testing
Good Manufacturing Practice
Software Development Methodology
GDP
Acceptance Testing
Scripting
Test Execution
Facilitation
URS
Risk Assessment
IQ
OQ
PQ
Documentation
Test Plans
Test Scripts
Interfaces
SAP
Oracle
LIMS
CMMS
Global Positioning System
Document Management
Collaboration
Quality Assurance
Computerized System Validation
Auditing
Master Data Management
MES
GAMP
Data Integrity
Job Details
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:
Knowledge/Skills:
Responsibilities:
Pay: $58-$60/hr
The post appeared first on .
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
The post appeared first on .
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