Manufacturing Execution Systems (MES) SME

🕒 September 18

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎁 Product Marketing

👻 Ghost score 17%

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Pinnaql

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Pinnaql is a life‑sciences technical and compliance services firm. It partners with pharmaceutical, biotechnology, radiopharma, cell & gene therapy (CGT), medical device companies, CDMOs and compounding pharmacies to deliver quality systems, lab and manufacturing technical operations, validation (CQV/CSV), automation and digital transformation, and engineering/project management support. Core services include QMS development and eQMS, regulatory and audit support, SOP/CAPA/deviation management, computer system validation and 21 CFR Part 11 compliance, LIMS and data integrity support, equipment and analytical method validation, commissioning/qualification/validation, process and cleaning validation, and automation/robotics integration. Pinnaql's experts embed with client teams to improve compliance, accelerate timelines, optimize manufacturing readiness and support tech transfer from development to commercialization. Offices are listed in Malvern, PA and Indianapolis, IN.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• Remote opportunity • Opportunity to make a meaningful difference by shaping the future of healthcare and technology • Purpose-driven, supportive team • Equal opportunity employment

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