CSV Engineer

cGxPServe; New Brunswick (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is looking for a Senior MES Engineer/Validation Lead to oversee computer system validation for Manufacturing Execution Systems supporting cell therapy manufacturing. This role is perfect for someone with a solid IT background and experience in the pharma/biotech sector. You will lead validation activities, ensuring compliance with regulations while collaborating with cross-functional teams. If you're passionate about quality assurance and thrive in dynamic environments, this is an exciting opportunity to make a significant impact in a vital industry.

Qualifications

• 3+ years of hands-on experience in pharma/biotech focusing on IT-Validation.
• Proven ability to manage competing priorities in fast-paced environments.

Responsibilities

• Lead end-to-end validation activities for Manufacturing Execution Systems.
• Collaborate with QA, Business, and IT to ensure compliant deployment of MES.

Skills

Computer System Validation (CSV)

Manufacturing Execution Systems (MES)

Quality Assurance & Compliance

Project Management

Cross-Functional Communication

Risk Assessments

GAMP 5

21 CFR Part 11

ALM

ServiceNow

Education

Bachelor's degree in Computer Science

Bachelor's degree in Information Systems

Bachelor's degree in Engineering

Tools

Syncade

SAP

Oracle

LIMS

SQL Databases

ALM

ServiceNow

Veeva

BMSDocs

Job description

Job description:
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.
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.

Requirements:

• 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.
• 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.
• Must Have 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.