Sandoz
Website:
sandoz.com
Job details:
Major Accountabilities
- Global Template stewardship: act as template keeper for MES; manage changes via Change Request and Design Review Boards; enforce standardization and consistent MES processes across sites.
- Manufacturing Execution processes: own functional and technical solution design for MES core capabilities including master data, recipe and bill‑of‑process management, electronic batch records (EBR), material handling, shop‑floor execution, deviations, and manufacturing documentation in a GxP environment.
- SAP S/4HANA integration: Lead and own integration between PAS‑X and SAP S/4HANA (PP, QM, inventory, batch management), ensuring consistent master data, order execution, material movements, confirmations, and batch status handling.
- Shop‑floor & automation integration: own integrations between PAS‑X and shop‑floor systems including equipment interfaces, PLC/SCADA, historians, and automation layers; ensure reliable, performant, and auditable data exchange.
- System integrations & interfaces: coordinate and govern integrations with surrounding manufacturing systems such as LIMS, and warehouse solutions, ensuring end‑to‑end process continuity.
- MES upgrade migrations: drive and support upgrades and system conversion of older MES versions to new MES versions, including data migration strategy and execution, validation impact assessment, and cutover planning.
- Validation ownership: plan and ensure delivery of validation deliverables per STEP SAP Validation & Quality Plans, including FRA/URS, FS/DS, IQ, OQ, PQ, summary reports, traceability matrices, and approvals in DMS.
- Testing orchestration: drive FUT, SIT, OQ, UAT, PQ; secure environments, data, and role provisioning; lead defect triage and sign offs.
- Security & compliance: coordinate application security activities (PT, pCMA) and provide evidence for all applicable Security Controls (IMF); ensure compliance and audit readiness.
- Release & service transition: Maintain the MES release roadmap aligned with STEP milestones; execute go live handover to AMS; maintain runbooks, KPIs, and operational support model.
- Documentation & governance: maintain end to end documentation in DMS/Confluence and delivery tooling (Jira/ALM); ensure URS → FS/DS → Test → Release traceability and controlled RICEFW lifecycle.
- Responsible for performing all assigned activities in compliance with GxP regulations, company SOPs, and data integrity requirements
Key Performance Indicators
- Timely and accurate LF reviews and budgeting process.
- Operational targets (including Talent, HC, I2P, Project and Service Delivery, Financials, Risk and Compliance, etc.) are met.
- Adherence to TT operating model and strategy.
- Effective collaboration model in place within and across TT functions.
- Adoption of New WoW by the Function (portfolio productization, number of associates trained/squad camps).
- Establishment and up-to-date strategic plan and portfolio.
Minimum Requirements
Work Experience:
- 5+ years of experience with Körber PAS‑X MES in regulated pharmaceutical manufacturing environments
- Strong understanding of Manufacturing Execution concepts including EBR, recipe management, shop‑floor execution, and material flows
- Hands on experience in MES upgrade projects (PAS-X) is highly valuable
- Proven experience integrating PAS‑X with SAP S/4HANA (PP, QM, inventory, batch management)
- Experience integrating MES with automation, PLC/SCADA, historians, and other shop‑floor systems
- Experience working in GxP / CSV‑regulated environments
Skills
- Strong understanding of change governance, configuration management, and Jira/ALM tooling
- Strong stakeholder and vendor management skills in global, multi‑site programs
- Excellent documentation, release, and operational readiness discipline
Languages
Education
Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field (Master’s degree preferred)
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