MES Engineer

Primary Talent Partners; Summit (NJ); On-site; USD 125,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior MES Engineer/Validation Lead to oversee computer system validation for Manufacturing Execution Systems. This role is tailored for professionals with a solid IT background and at least three years of experience in the pharma or biotech sector. The successful candidate will collaborate with QA and IT teams to ensure compliant deployment of MES solutions. Join a dynamic team where your expertise will contribute to advancing cell therapy manufacturing processes. This is a fantastic opportunity to make a significant impact in a fast-paced environment.

Qualifications

• 3+ years experience in pharma/biotech focusing on IT-Validation.
• Strong understanding of MES Syncade & Recipes testing phases.

Responsibilities

• Lead validation activities for Manufacturing Execution Systems.
• Ensure compliance with 21 CFR Part 11 and internal SOPs.

Skills

Computer System Validation

Cross-functional Communication

GMP Compliance

Risk Assessment

Project Management

Education

Bachelor’s degree in Computer Science

Bachelor’s degree in Information Systems

Bachelor’s degree in Engineering

Tools

Syncade MES

SQL Databases

ServiceNow

ALM

Job description

6 days ago Be among the first 25 applicants

Primary Talent Partners provided pay range

This range is provided by Primary Talent Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55.00/hr - $60.00/hr

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.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering and Information Technology

• Industries

  Staffing and Recruiting

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