Role Overview:The Senior SAP PM and Calibration Consultant will be a highly skilled expert responsible for the end-to-end design, configuration, and deployment of complex asset management and quality processes within SAP S4HANA, specifically in a strictly regulated environment. This role focuses on architecting and managing core maintenance streams, including corrective, preventive, and high-priority breakdown workflows, alongside integrated calibration loops connecting Plant Maintenance with Quality Management. The consultant will ensure regulatory compliance, GxP standards, and Computer System Validation protocols are met, particularly in medical device manufacturing, by ensuring robust audit trails and traceability. This position also involves bridging technical execution with business needs, leading workshops, and driving critical integrations across various SAP modules and third-party systems.
Key Responsibilities:- Own the end-to-end design, configuration, and deployment of complex asset management and quality processes using SAP S4HANA.
- Architect and manage core maintenance streams, including corrective, preventive, and high-priority breakdown workflows.
- Manage tightly integrated calibration loops that connect Plant Maintenance with Quality Management.
- Configure crucial data objects such as functional location hierarchies, equipment master records, notifications, work orders, task lists, and equipment Bills of Materials.
- Configure calibration-specific data like Master Inspection Characteristics and sampling procedures.
- Ensure all workflows feature robust audit trails and flawless traceability during compliance audits, adhering to regulatory compliance, GxP standards, and Computer System Validation protocols.
- Lead workshops with maintenance, quality assurance, and laboratory teams.
- Drive critical integrations across other SAP modules, including Materials Management, Production Planning, and Finance.
- Design seamless interfaces with third-party metrology software and calibration bolt-on systems to synchronize master inspection characteristics, test results, and device statuses.
- Leverage standard SAP middleware (such as BTP, PIPO, or IDocs/APIs) to connect mobile maintenance tools or asset tracking systems.
- Ensure all external interfaces comply with GxP and Computer System Validation (CSV) protocols, maintaining unbroken audit trails.
Required Skills:- SAP Plant Maintenance (PM)
- SAP Quality Management (QM)
- SAP S4HANA
- Regulatory compliance (GxP standards, Computer System Validation protocols)
- Experience in medical device manufacturing
- Configuration of functional location hierarchies, equipment master records, notifications, work orders, task lists, equipment Bills of Materials
- Configuration of Master Inspection Characteristics and sampling procedures
- SAP middleware (BTP, PIPO, IDocs/APIs)
Qualifications:- 8-10 years of experience in SAP Plant Maintenance and Calibration.
- Proven track record of delivering 2 to 3 full-lifecycle, validated implementations.
- Deep expertise in regulatory compliance, GxP standards, and Computer System Validation protocols.
