MES Recipe Architect/Recipe Designer

Full-time

Xtellia

About the Company

Xtellia LLC is a technology and consulting company focused on helping manufacturers improve operations through Operational Technology (OT), Manufacturing Execution Systems (MES), automation, data, and digital transformation .

We work with leading life sciences and other highly regulated manufacturers to design and implement practical, scalable solutions that connect manufacturing processes, people, equipment, and enterprise systems.

Our team combines deep expertise in MES, automation, manufacturing engineering, systems integration, and regulated environments to help clients modernize manufacturing operations and transition from paper-based and legacy processes to modern, data-driven solutions.

Job Description

As an MES Recipe Architect / Recipe Designer , you will be responsible for the architecture, design, and hands-on authoring of MES Master Recipes and Electronic Batch Records (EBRs) using Rockwell PharmaSuite MES .

You will work directly with clients to understand their manufacturing processes, lead requirements-gathering and design workshops, and translate business and manufacturing requirements into effective, scalable, and compliant electronic recipes .

This is a hands-on role requiring the ability to architect, design, and author PharmaSuite Master Recipes from scratch . You will participate throughout the complete recipe lifecycle, including requirements gathering, recipe design, configuration, testing, validation, deployment, and ongoing optimization .

The ideal candidate is a senior MES subject matter expert with extensive experience in pharmaceutical or biopharmaceutical manufacturing, GMP/cGMP, 21 CFR Part 11, data integrity, and Electronic Batch Records .

Required Qualifications

10+ years of MES experience , with significant experience in life sciences manufacturing.
Deep, hands-on experience with Rockwell PharmaSuite MES .
Demonstrated experience architecting, designing, and authoring master recipes and EBRs from scratch .
Strong experience with PharmaSuite recipe authoring and configuration .
Strong experience working in GMP/cGMP-regulated pharmaceutical or biopharmaceutical environments .
Strong practical knowledge of 21 CFR Part 11 and ALCOA+ data integrity principles .
Experience working within CSV/CSA, validation, qualification, and controlled change environments .
Experience leading client-facing requirements-gathering and design workshops.
Strong understanding of ISA-88/S88 and ISA-95/S95 principles.
Experience with MES integration and data flows involving SAP, LIMS, FactoryTalk Batch, and automation systems .
Excellent communication, presentation, and client relationship skills.
Ability to work independently in a remote consulting environment.
Willingness to travel up to 60% to client sites.

Preferred Qualifications

Bachelor's degree in Engineering, Computer Science, Automation, Life Sciences, or a related field.
Experience with Rockwell FactoryTalk Batch and PlantPAx.
Experience with pharmaceutical, biopharmaceutical, biologics, sterile, API, vaccine, cell and gene therapy, or medical device manufacturing.
Experience supporting FDA-regulated facilities, inspections, or inspection readiness.
Experience with AVEVA PI/OSIsoft PI or other manufacturing historians.
Experience with OPC/OPC UA, REST APIs, SQL, or other manufacturing integration technologies.
Experience with multi-site PharmaSuite deployments.
Experience migrating recipes from legacy MES/EBR platforms to PharmaSuite.

Apply

Vacancy posted 15 hours ago

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