Sr. MES SME

Pinnaql; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

Pinnaql, Inc. is seeking an MES Subject Matter Expert to support manufacturing operations and digital manufacturing initiatives in regulated environments.

You will lead MES configuration, optimization, and lifecycle activities, while ensuring robust data flow with PAS-X, DeltaV, and SAP integrations. Collaborating with Manufacturing, Automation, Quality, IT/OT, and Validation teams, you will help maintain GMP compliance, electronic batch records, and validated systems.

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.
• Strong hands-on knowledge of Werum/Körber PAS-X.
• 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.

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.

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

Description

• 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.
• Strong hands‑on knowledge of Werum/Körber PAS‑X.
• 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 Pinnaql, 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.

Pinnaql 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.