Position Purpose
The Technical Expert – Global MS&T; (Sterile), based in the Capability Hub, provides specialized technical support and product stewardship for sterile/aseptic manufacturing processes at assigned Sandoz manufacturing.

Your Key Responsibilities
Your responsibilities include, but not limited to

Technical Support & Product Stewardship (Sterile/Aseptic)
- Provide technical expertise to sterile manufacturing sites in areas such as aseptic process design, equipment capability, utilities readiness, and troubleshooting. Act as the technical steward for assigned sterile products/processes to ensure operations remain validated, controlled, and contamination‑free. Support sterile process performance verification (CPV), EM/aseptic data review, and improvement initiatives to enhance process robustness. Ensure sterile operations remain in a validated and compliant state per MS&T; expectations, regulatory guidelines (EU Annex 1), and contamination control principles. Contribute to sterile investigations and preparation of OPV reports, PPQ documentation, regulatory responses,



and scale‑up/aseptic capability assessments.

Validation & Compliance
- Support process validation and cleaning validation activities for drug substance and drug product at assigned manufacturing sites. Support equipment, utilities, and facility qualification including IQ/OQ/PQ for sterile systems (autoclaves, de-pyrogenation tunnels, isolators/RABS, SIP systems, WFI/PW/clean steam, HVAC). Support media fills/aseptic process simulation (APS) and cleaning/sterilization validation activities for assigned products and sites. Contribute to review of validation protocols and reports to ensure scientific robustness and compliance with global regulatory expectations. Ensure availability and accuracy of sterile‑related technical documentation ahead of qualification, validation, or technical change activities. Provide technical assessments for deviations, change controls, CAPAs, EM/contamination events,

📌 Technical Expert MS&T-Sterile (Telangana)
🏢 Sandoz India
📍 Telangana