MES Engineer

Overview

On Site
$55 - $60 hr
Contract - W2
Contract - Independent
Contract - 6+ mo(s)

Skills

Manufacturing Execution System
Scripting
Test Execution
Facilitation
URS
Risk Assessment
OQ
PQ
Test Plans
Test Scripts
Interfaces
SAP
Oracle
LIMS
CMMS
Global Positioning System
Collaboration
Computerized System Validation
Auditing
Master Data Management
Data Integrity
Management
Communication
Testing
IQ
System Testing
Acceptance Testing
Good Manufacturing Practice
GAMP
Software Development Methodology
Documentation
GDP
Computer Science
Information Systems
Pharmaceutics
FOCUS
Quality Assurance
Regulatory Compliance
MES
Application Lifecycle Management
ServiceNow
SQL
Database
Document Management
Process Automation
Manufacturing
Recruiting
PTP

Job Details

Primary Talent Partners has a 6 month contract opening for a MES Engineer to join a major pharma client for a position.

Pay: $55.00-60.00/hr based on experience and academia
W2 Contract: 6 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship
Location: Onsite - Summit, NJ

Overview: 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
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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