Sr. MES SME at Pinnaql in Remote

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.

We are seeking an experienced Manufacturing Execution Systems (MES) Subject Matter Expert (SME) to support a leading life sciences manufacturing organization. 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.

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. Interested candidates may reach out directly or submit their resume for consideration.

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.

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