Manufacturing Execution Systems (MES) Manager

Manufacturing Execution Systems (MES) Manager

POSITION SUMMARY

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing IT professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Senior Director, Information Systems at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

The Manufacturing Execution Systems (MES) Manager will drive efficiency and reliability in our manufacturing processes. This role involves developing MES support strategies, collaborating with vendors, optimizing system performance, and ensuring compliance with GxP regulations.

ESSENTIAL FUNCTIONS

• Develop and maintain a MES support strategy that integrates manufacturing process knowledge, equipment design, and quality standards with information technology to reduce downtime.
• Collaborate closely with the enterprise and external vendors to evaluate and implement MES application upgrades, hotfixes, and enhancements.
• Continuously monitor MES system performance, review logs, and diagnostic data, and respond appropriately to ensure optimal operation.
• Acquire a deep understanding of manufacturing processes and system configurations to provide well-informed recommendations for system optimization.
• Utilize strong technical writing skills to update SOPs, reference materials, and other controlled content.
• Provide on-call support for EBR/APS systems as needed to maintain uninterrupted operations.
• Mentor and train new MES resources, both internal and external, to foster a skilled and knowledgeable team.
• Manage software and configurations required for external system interfaces, facilitating seamless data exchange.
• Contribute to, facilitate, review, and update system development lifecycle and validation documents as needed for GxP IT implementation and enhancement projects.
• Support multiple ongoing IT initiatives within the MES environment, aligning technology solutions with business requirements.
• Evaluate business requirements and propose effective solutions, actively engaging with end users and stakeholders to plan and execute system enhancements and related changes.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• Possess Pharmaceutical, Biotechnology, or Life Science industry experience.
• A Bachelor's degree in Computer Sciences, Information Technology, or Business Administration is required.
• Must have a 5-year proven track record performing in enterprise systems, including 5+ years of extensive MES solution deployment experience.
• Knowledge and experience with MES technologies.
• Experience leading and supporting enterprise large scale and other mission-critical applications like: Siemens MES.
• Siemens OpCenter Execution Pharma (EBR) and OpCenter APS (Scheduling) would be preferable.
• Database administration knowledge for Oracle, SQL and/or other platforms is preferable
• Knowledge of business intelligence platforms such as PowerBI and other data ETL and modeling tools is preferred
• Demonstrated leadership skills and experience working in diverse, multi-disciplined work groups.
• Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity.

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