Description:
We are seeking an experienced Manufacturing Systems Integration Specialist to support the deployment, configuration, and validation of MES solutions in a regulated life sciences environment. The ideal candidate will have a strong background in recipe configuration, system validation, and integration of MES with ERP and other enterprise systems.
Responsibilities:
- Lead or support the deployment and maintenance of MES (e.g., POMS) across manufacturing lines, including paper-to-digital transitions.
- Design and configure manufacturing recipes and workflows within MES platforms.
- Author validation documentation and execute system validation activities in compliance with industry standards.
- Integrate MES systems with ERP (SAP, Oracle), equipment management (Infor, Maximo), and training systems (Isotrain, ComplianceWire).
- Utilize document management systems (e.g., Windchill, M-Files, TCE) for software documentation and change control.
- Collaborate with cross-functional teams including QA, IT, and operations to ensure system compliance and performance.
Qualifications:
- 5–10 years of experience with MES system deployment and maintenance.
- Minimum 5 years of experience in recipe design/configuration and system validation.
- Familiarity with GxP, pharma/medical device software lifecycle (SLC), and validation processes.
- Experience deploying MES in paper-based manufacturing environments.
- Knowledge of system integration, documentation management, and regulatory requirements.
- Preferred: Experience deploying MES on Windows/Oracle platforms and understanding of cybersecurity requirements in life sciences.