Role and Responsibilities:
The role involves digitalizing multiple sites across various geographies by implementing MES systems coupled with Data Historian, and establishing connectivity to SAP systems for planning or inventory management.
Main Responsibilities:
* Lead and manage MES projects (PAS-X, Opcenter, AspenTech), ensuring successful implementation and delivery.
* Handle Siemens OpcenterEXPH modules, including user management, material flow management, and equipment management.
* Oversee SAP-MES interface integration, report development, and L2 integrations.
* Ensure compliance with industry standards (21CFR Part 11, GAMP, cGMP, EU Annex 11) and perform Computer Systems Validation (CSV).
* Provide technical leadership, addressing challenges in system architecture, SQL, and JavaScript.
Requirements:
* 8+ years of implementation experience in MES systems.
* Experience in MES project management, with a strong track record of delivering projects using Siemens Opcenter, PAS-X, and AspenTech.
* Good knowledge of MES Siemens Opcenter Pharma MBR Designing, Architectural SQL, and JavaScript.
* Knowledge of pharmaceutical manufacturing processes – life sciences and healthcare.
* Proven experience in managing Siemens OpcenterEXPH modules, including weighing & dispensing, equipment management, and PI process.
* Solid understanding of SAP-MES interface integration, L2 integrations, and report development to streamline operations.
* In-depth understanding of ISA S88/S95 models, Computer Systems Validation, 21CFR Part 11, cGMP standards, and related regulations.
* Experience with other MES applications like Werum PAS-X, Aspentech Manufacturing Suite, or Schneider Electronic Batch Record is an added advantage.
About the Job:
This is a contract position with a stable work environment and a supportive team. The job offers a good balance between work and personal life.