Senior MES Engineer/Validation Lead

Seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. T

Partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions.

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. 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

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

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,Docs), supporting testing, issue tracking, and controlled documentation.

A strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.