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MES Support Engineer - Wilson, NC. Hybrid jobs in United States
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Bravens Inc. · 8 hours ago

MES Support Engineer - Wilson, NC. Hybrid

positionCharlotte, NC
timeContract
remoteHybrid
senioritySenior Level
date5+ years exp
Bravens Inc. is seeking a MES Support Engineer to join their team. The role involves configuring and maintaining Werum PAS X in pharmaceutical or biotech manufacturing environments, ensuring compliance with regulatory standards and facilitating integration with peripheral systems.
ConsultingInformation TechnologyProject ManagementStaffing Agency
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H1B Sponsor Likelynote

Responsibilities

Proven hands-on experience configuring and maintaining Werum PAS X (MES) in pharmaceutical or biotech manufacturing environments
Strong understanding of pharmaceutical GMP, electronic batch records, and computerized system validation (CSV), including IQ/OQ/PQ documentation
Practical knowledge of MES concepts and standards (ISA 88, ISA 95) and how they map to PAS X configuration
Experience integrating PAS X with peripheral systems: SAP (PP/PI or MII), LIMS, ERP, PLC/SCADA, and historians (interfaces via IDocs, XML/REST, OPC, or web services)
Strong troubleshooting and test-case execution skills, with attention to traceability and regulatory compliance during deployments and change management
Excellent communication skills, ability to work with cross-functional teams (TQ /EQ, Production, IT)
Previous involvement in full lifecycle MES implementations (requirements, design, build, test, go live, hypercare)
Knowledge of electronic signatures, audit trails, and 21 CFR Part 11 requirements
Certifications in PAS X

Qualification

Werum PAS XPharmaceutical GMPMES conceptsSAP integrationElectronic signaturesTroubleshooting skillsCommunication skillsCross-functional teamwork

Required

Bachelor's degree in Engineering, Computer Science, Information Systems, or equivalent practical experience
Proven hands-on experience configuring and maintaining Werum PAS X (MES) in pharmaceutical or biotech manufacturing environments
Strong understanding of pharmaceutical GMP, electronic batch records, and computerized system validation (CSV), including IQ/OQ/PQ documentation
Practical knowledge of MES concepts and standards (ISA 88, ISA 95) and how they map to PAS X configuration
Experience integrating PAS X with peripheral systems: SAP (PP/PI or MII), LIMS, ERP, PLC/SCADA, and historians (interfaces via IDocs, XML/REST, OPC, or web services)
Strong troubleshooting and test-case execution skills, with attention to traceability and regulatory compliance during deployments and change management
Excellent communication skills, ability to work with cross-functional teams (TQ /EQ, Production, IT)
5+ years of strong experience in PAS-X Modelling and Support
Pharmaceutical Process Knowledge & GxP Compliance
Technical Integration & Data Systems
11+ Years of Experience

Preferred

Previous involvement in full lifecycle MES implementations (requirements, design, build, test, go live, hypercare)
Knowledge of electronic signatures, audit trails, and 21 CFR Part 11 requirements
Certifications in PAS X

Company

Bravens Inc.

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Bravens is an Information Technology Consulting and Services company with the vast experience, full of success stories in the service of many companies and organizations in general.
dateFounded in 2010
location
Chantilly, Virginia, USA
people-size501-1000 employees
web-link
https://www.bravensinc.com/

H1B Sponsorship

Bravens Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)

Funding

Current Stage
Late Stage
Company data provided by crunchbase