Validation Engineer

Net2Source Inc.; New Jersey; On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Senior MES Engineer/Validation Lead to oversee computer system validation activities for Manufacturing Execution Systems (MES) in the dynamic field of cell therapy manufacturing. This role requires a solid IT and Computer Science foundation, along with significant hands-on experience in the pharma and biotech sectors. You'll work closely with cross-functional teams to ensure compliant deployment of MES solutions, making a meaningful impact in a fast-paced environment. If you thrive on challenges and have a passion for quality assurance, this position is tailored for you.

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 validation activities including test preparation and execution.
• Develop and execute validation deliverables like URS and Risk Assessments.
• Collaborate with QA and IT to ensure compliance.

Skills

Computer System Validation (CSV)

MES experience with Emerson Syncade

Project management

ALM, ServiceNow, SQL databases

Education

Bachelor's degree in Computer Science

Bachelor's degree in Information Systems

Tools

Emerson Syncade

SAP

LIMS

Oracle

Veeva

BMSDocs

Job description

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This range is provided by Net2Source Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $60.00/hr

Direct message the job poster from Net2Source Inc.

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Job Title: MES Validation Engineer

Location: Summit West, NJ/ Giralda Farms, NJ/ Princeton Pike, NJ/ Lawrenceville, NJ/ New Brunswick, NJ

Job Duration: 06+ Months (Extendable)

Pay Rate: $60.71/hr on W2

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

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

• 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.

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

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)

Regards,

Kajal Singh

Senior IT Recruiter (Pharma and Life Sciences)

Net2Source Inc.

Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Office: [phone] x 980 | Cell: [phone] | Fax: [phone]| Email: [e-mail]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering, Manufacturing, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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