MES Engineer
MES Engineer
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1 Vacancy
Job Description
Hi
We have an opportunity for MES Engineer with Direct Client . Below is the detailed job description along with the client details and work location. If you are in the market or looking for a change please respond with the following information or do call me at Ext 116.
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 handson 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 crossfunctional 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.
Holds a Bachelors degree in Computer Science or a related technical discipline
o Key Responsibilities
Lead endtoend validation activities including test preparation authoring of IQ/System/UAT scripts Dry Run test data setup environment readiness test facilitation and postexecution 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 auditready.
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 fastpaced crossfunctional environments.
Experienced in crossfunctional 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
Bachelors 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
Employment Type
Full Time
