MES Engineer
Job Number: 25-04255
Job Number: 25-04255
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an MES Engineer for our client in Summit, NJ.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- 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.
- Will 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.
Required Qualifications:
- 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.
- 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.
Pay Rate: $60 - $64 / Hour
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
646-695-2942
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
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