APP&SYS ENG - MES Engineer MES Engineer

Mindlance; Summit (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior MES Engineer/Validation Lead to spearhead computer system validation for Manufacturing Execution Systems. This role is perfect for someone with a solid IT foundation and a minimum of 3 years in the pharma/biotech sector. The successful candidate will collaborate with cross-functional teams to ensure compliance and efficiency in MES deployment. With a focus on quality assurance and compliance, this position offers a unique opportunity to impact the manufacturing process significantly. If you thrive in fast-paced environments and have a passion for system validation, this is the role for you.

Qualifications

• 3+ years of experience in pharma/biotech focusing on IT Validation.
• Strong understanding of compliance regulations and validation processes.

Responsibilities

• Lead validation activities for Manufacturing Execution Systems (MES).
• Develop validation deliverables and ensure compliance with regulations.

Skills

System Validation

Cross-Functional Communication

Project Management

Compliance Knowledge

Education

Bachelor's in Computer Science

Engineering Discipline

Tools

Syncade MES

ALM

ServiceNow

SQL Databases

Job description

Job Description: o 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.

o 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.

o 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.

o 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
Additional Job Requirements:
None

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”