MES Engineer

Position : MES Engineer

Location : CA, USA

Experience : 4+ Years

Employment Type : 12+ months Contract

Job Overview

We are looking for an experienced MES Engineer Recipe Author with strong hands-on expertise in Rockwell PharmaSuite to support manufacturing systems and digital operations within a regulated pharmaceutical environment. The role involves designing, developing, and maintaining MES recipes, workflows, and electronic batch records (eBRs) while ensuring adherence to GMP standards and system validation requirements.

You'll collaborate closely with cross-functional teams including manufacturing, automation, quality assurance, and IT to drive MES integration, system enhancements, and process efficiency initiatives across the production floor.

Key Responsibilities

Design, configure, and author MES recipes and workflows using Rockwell PharmaSuite .

Develop and maintain Electronic Batch Records (eBR) ensuring compliance with GMP and validation standards.

Work with process engineers and manufacturing teams to translate process requirements into MES functional designs.

Support MES integration with ERP, automation, and data systems.

Troubleshoot MES-related issues and coordinate with technical teams for timely resolution.

Participate in system testing, validation, and documentation activities (URS, FRS, IQ / OQ / PQ).

Maintain system change controls, audit trails, and ensure data integrity.

Provide end-user training, support, and ongoing system optimization.

Required Skills & Experience

Minimum 4+ years of MES experience within pharmaceutical or biotech manufacturing .

Strong hands-on experience with Rockwell PharmaSuite MES (recipe authoring, configuration, deployment).

Sound understanding of GMP, GxP, and FDA 21 CFR Part 11 compliance.

Proven experience in system validation and documentation within regulated environments.

Knowledge of ISA-88 / ISA-95 standards and batch process control concepts.

Experience integrating MES with automation systems and enterprise platforms.

Excellent communication and teamwork skills, with a focus on cross-functional collaboration.

Bachelor's degree in Engineering, Computer Science, or a related technical discipline.

Nice-to-Have

Exposure to other MES platforms (Werum PAS-X, Syncade, etc.).

Experience in pharma manufacturing processes (formulation, filling, packaging).

Understanding of data historian and analytics tools for MES performance monitoring.