Systems Manager
7 days ago
Job Description
We are seeking an MES Systems Manager to oversee and support our Manufacturing Execution System (MES) environment, ensuring reliability, compliance, and alignment with manufacturing operations. This role is highly collaborative, sitting between the business and IT vendors, and requires someone who understands life sciences manufacturing systems and can translate business needs into system requirements. The position does not involve coding or configuration work within the MES but instead focuses on vendor management, system optimization, and ensuring that MES capabilities are leveraged effectively to support compliant, efficient operations.
This role is based at our Burlington, MA facility (with occasional travel to Cambridge as needed), working onsite Monday–Thursday with remote flexibility on Fridays (additional remote flexibility available).
Day-to-Day
- Develop and maintain MES support strategies that integrate knowledge of manufacturing processes, equipment, and compliance requirements with system capabilities.
- Serve as the key liaison between internal stakeholders and external MES vendors/managed service providers, overseeing system enhancements, upgrades, and support.
- Monitor MES system performance, review logs and diagnostic data, and ensure timely resolution of issues to minimize downtime.
- Partner with Manufacturing teams to understand processes, provide informed recommendations, and ensure system use aligns with operational and compliance needs.
- Manage vendor contracts, invoices, and performance to ensure quality of service and cost control.
- Review and update SOPs, reference materials, and validation documents to maintain regulatory compliance (GxP, 21 CFR Part 11, Annex 11, etc.).
- Support multiple ongoing IT initiatives within the MES environment, aligning business requirements with system capabilities.
- Provide input on system feasibility and best practices, helping the business understand what is and isn't possible within Siemens Opcenter MES platforms.
Requirements / Qualifications
- Bachelor's degree in Computer Science, Information Technology, Business Administration, or related discipline.
- 5–8 years of experience supporting manufacturing IT systems; prior MES support experience required.
- Direct experience in the life sciences industry (pharma or biotech preferred; medical devices acceptable).
- Familiarity with Siemens Opcenter Execution Pharma (EBR) and Opcenter APS (Scheduling) strongly preferred but not strictly required.
- Strong background in vendor/managed service management, including oversight of contracts and invoices.
- Knowledge of Oracle/SQL databases, BI platforms (e.g., PowerBI), and data modeling tools is a plus.
- Solid understanding of regulated environments, including GxP, GAMP 5, 21 CFR Part 11, and data integrity principles.
- Excellent communication and cross-functional collaboration skills.
- Experience as a Sr. Systems Administrator or similar IT applications support role within life sciences manufacturing is highly desirable.
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