What are the responsibilities and job description for the MES Project Manager position at TekOne IT Services Pvt. Ltd.?
Job Description
We are seeking an experienced MES Implementation Project Manager with a strong background in Medical Device regulations and manufacturing systems to lead and drive the successful deployment of Manufacturing Execution Systems (MES) in a regulated environment. The ideal candidate will have a proven track record in project management, MES implementation, and a deep understanding of compliance in the medical device industry.
Key Responsibilities
We are seeking an experienced MES Implementation Project Manager with a strong background in Medical Device regulations and manufacturing systems to lead and drive the successful deployment of Manufacturing Execution Systems (MES) in a regulated environment. The ideal candidate will have a proven track record in project management, MES implementation, and a deep understanding of compliance in the medical device industry.
Key Responsibilities
- Lead end-to-end MES implementation projects, ensuring alignment with business objectives, regulatory requirements, and timelines.
- Define project scope, goals, and deliverables, while managing project resources and budget.
- Develop detailed project plans, schedules, and risk mitigation strategies to ensure timely and successful project execution.
- Coordinate with cross-functional teams including engineering, quality, IT, and production, to deliver seamless MES integration.
- Drive collaboration between internal stakeholders and external vendors to ensure project success.
- Lead the deployment and integration of MES platforms such as CM, Apriso, Opcenter, SAP ME, and Aveva MES.
- Analyze existing manufacturing processes and identify areas for MES optimization and automation.
- Oversee system design, configuration, and validation processes to ensure compliance with regulatory standards.
- Ensure data integrity and seamless connectivity between MES and ERP systems (e.g., SAP).
- 5 years of experience in Project Management with a focus on MES implementation in the manufacturing or medical device industry.
- Expertise in MES platforms: Experience with at least one of the following systems: CM, Apriso, Opcenter, SAP ME, Aveva MES, or similar MES platforms.
- Medical Device Industry Knowledge: In-depth knowledge of medical device regulations (FDA, ISO 13485, GMP) and experience ensuring MES compliance.
- Strong understanding of manufacturing processes, particularly in highly regulated environments.
- Proven ability to manage projects through the full lifecycle, including planning, execution, monitoring, and closure.
- Leadership skills to manage cross-functional teams and effectively communicate with stakeholders at all levels.
- Technical understanding of MES-ERP integrations, data management, and manufacturing process automation.
