Snr. Solution Analyst – Körber PAS X – Manufacturing Execution

Job Description Summary

Serve as the Solution Analyst for Körber PAS‑X Manufacturing Execution, performing Technical System Owner–like responsibilities for global MES solutions within STEP. You will safeguard the STEP Global MES Template, orchestrate build & run activities, and ensure compliant delivery and operation across projects — including validation, integrations, security controls evidencing, and audit readiness.

Job Description

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:

• English.

Education:

Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field (Master’s degree preferred)

Skills Desired

Analytical Thinking, Business Acumen, Change Management, Influencing, IT Governance, Organization Development, Planning, Presentation Skills, Servant Leadership, Stakeholder Management

Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.

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