Manufacturing Execution Systems (MES) SME

Pinnaql, Inc.; Northern (KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an experienced MES Subject Matter Expert to drive manufacturing execution systems in regulated environments. You will lead MES configurations, integrations with PAS-X, DeltaV and SAP, and lifecycle activities across multiple site projects.

You will collaborate with Manufacturing, Automation, Engineering, Quality, IT/OT and Validation teams to ensure compliant, data‑driven operations and robust system performance.

Qualifications

• Experience supporting MES in pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Strong knowledge of GMP computerized systems, commissioning/qualification, validation, change control, deviations, and lifecycle activities.
• Ability to work cross-functionally with Manufacturing, Automation, Engineering, Quality, IT/OT and Validation teams.

Responsibilities

• Serve as the MES Subject Matter Expert supporting manufacturing operations and digital manufacturing initiatives.
• Provide technical leadership for MES configuration, implementation, optimization, troubleshooting, and lifecycle support.
• Support integration and data flow between PAS-X, DeltaV, SAP, and associated manufacturing systems.
• Lead or support system changes, upgrades, testing, commissioning, qualification, and validation activities.
• Develop and maintain technical documentation, procedures, specifications, and system lifecycle documentation.

Skills

MES expertise

GMP familiarity

Cross-functional collaboration

Troubleshooting

Documentation

Education

Bachelor’s degree in Engineering, Computer Science, Automation, Information Systems, or a related technical discipline

Tools

PAS-X

Emerson DeltaV

SAP integrations

Job description

Manufacturing Execution Systems (MES) SME

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Manufacturing Execution Systems (MES) SME

The ideal candidate will bring strong experience with MES platforms and integrated manufacturing systems, with particular expertise in PAS-X, DeltaV, and SAP within a regulated GMP environment.

Key Responsibilities

• Serve as the MES Subject Matter Expert supporting manufacturing operations and digital manufacturing initiatives.
• Provide technical leadership for MES configuration, implementation, optimization, troubleshooting, and lifecycle support.
• Support integration and data flow between PAS-X, DeltaV, SAP, and associated manufacturing systems.
• Partner with Manufacturing, Automation, Engineering, Quality, IT/OT, and Validation teams to ensure reliable and compliant system performance.
• Support electronic batch records, master batch record configuration, manufacturing workflows, recipes, and system interfaces.
• Lead or support system changes, upgrades, testing, commissioning, qualification, and validation activities.
• Troubleshoot complex MES and system-integration issues and drive root-cause resolution.
• Ensure solutions comply with GMP, data integrity, computerized system validation, and applicable regulatory requirements.
• Develop and maintain technical documentation, procedures, specifications, and system lifecycle documentation.
• Provide technical guidance and mentorship to project and site teams.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Automation, Information Systems, or a related technical discipline.
• Demonstrated experience supporting MES in pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience with Emerson DeltaV and SAP integrations in a manufacturing environment.
• Strong understanding of electronic batch records, manufacturing workflows, automation integration, and production systems.
• Experience supporting GMP computerized systems, commissioning/qualification, validation, change control, deviations, and system lifecycle activities.
• Strong troubleshooting, communication, and cross-functional collaboration skills.
• Experience integrating MES, automation, and enterprise systems in complex pharmaceutical manufacturing environments is highly preferred.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.