MES Validation engineer - W2 only

TSR Consulting Services, Inc.; New Brunswick (NJ); Hybrid; USD 125,000 - 150,000; Full time

Job summary

An established industry player is seeking a MES Engineer/Validation Engineer to oversee computer system validation for Manufacturing Execution Systems (MES) in the biotech sector. This role demands a strong IT foundation and hands-on experience in the pharmaceutical industry. You will lead validation activities, ensuring compliance with industry standards, and collaborate with cross-functional teams to deliver efficient solutions. If you thrive in dynamic environments and have a passion for quality assurance in technology, this opportunity is perfect for you.

Benefits

Medical insurance

Vision insurance

401(k) plan

Qualifications

• 4+ years of CSV experience in regulated environments.
• 3+ years of hands-on MES experience with recipe validation.
• 2+ years of project management experience.

Responsibilities

• Lead end-to-end validation activities for MES.
• Develop and execute validation deliverables and documentation.
• Collaborate with QA and IT for compliant deployment.

Skills

Computer System Validation (CSV)

MES experience with Emerson Syncade

Project management

ALM and ServiceNow

SQL databases

Document management systems

Education

Bachelor’s degree in Computer Science

Tools

Emerson Syncade

SAP

LIMS

Oracle

ALM

ServiceNow

Job description

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TSR Consulting Services, Inc. provided pay range

This range is provided by TSR Consulting Services, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$58.00/hr - $60.00/hr

Direct message the job poster from TSR Consulting Services, Inc.

Job ID # 82365

Rate type: W2 only

Candidates must be onsite 50% of the time at either Summit, NJ, Madison, NJ, Lawrenceville, NJ or New Brunswick, NJ

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

o About the Role

We’re seeking a MES Engineer/Validation engineer 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.

o 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.

-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.

o 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology and Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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