MES Engineer

Cynet Systems Inc; Summit (NJ); On-site; USD 125,000 - 150,000; Full time

Job summary

An established industry player is seeking a skilled Validation Specialist to lead end-to-end validation activities in a dynamic environment. This role involves developing and executing validation deliverables, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. The ideal candidate will have a deep understanding of MES Syncade, electronic batch records, and validation practices. If you're passionate about quality assurance and thrive in a fast-paced setting, this opportunity offers a chance to make a significant impact in the pharmaceutical and biotech sectors.

Qualifications

• 3+ years of experience in pharma/biotech with focus on IT Validation.
• Proven ability to manage competing priorities in fast-paced environments.
• Deep understanding of MES Syncade and Recipes testing phases.

Responsibilities

• Lead validation activities including test preparation and execution.
• Develop validation deliverables like URS and Risk Assessments.
• Ensure compliance with GAMP 5 and 21 CFR Part 11.

Skills

Cross-functional communication

System validation

Test preparation and execution

Compliance with 21 CFR Part 11

Risk assessments

Education

Bachelor’s degree in Computer Science

Bachelor’s degree in Information Systems

Bachelor’s degree in related engineering discipline

Tools

ALM

ServiceNow

SQL databases

Document management systems

Job description

Job Description:

Pay Range: $52hr - $59hr

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 and 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.