MES - Validation Engineer

Hays; Princeton (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled MES - Validation Engineer to lead validation activities in a dynamic environment. This role involves managing end-to-end validation processes, ensuring compliance with industry standards, and collaborating with cross-functional teams. You'll leverage your expertise in Computer System Validation and MES platforms to drive quality assurance and compliance in a regulated setting. Join a forward-thinking organization that values diversity and offers comprehensive benefits, including medical, dental, and 401K plans. If you're passionate about validation and eager to make an impact, this opportunity is perfect for you!

Benefits

Full medical benefits

Dental benefits

Vision benefits

401K

Life Insurance ($20,000 benefit)

Qualifications

• 4+ years of Computer System Validation experience in pharma/biotech.
• Experience with MES platforms and electronic batch records.
• Strong knowledge of GAMP 5 and 21 CFR Part 11 compliance.

Responsibilities

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

Skills

Computer System Validation (CSV)

MES Syncade

GAMP 5

Quality Assurance

Project Management

SQL Databases

ServiceNow

Communication Skills

Education

Bachelor’s degree in Computer Science

Bachelor’s degree in Information Systems

Tools

ALM

ServiceNow

SQL databases

Veeva

BMSDocs

Job description

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking MES - Validation Engineer in Princeton, NJ.

Role Description

• 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.

Skills & Requirements

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.

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

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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#1171681 - Michal Mercier