Technical Expert MS&T-Sterile

Job description

Job Description Summary 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 sites and external suppliers (CMOs). The role ensures robust, compliant, and well-controlled sterile operations through hands-on support in equipment/utilities qualification, aseptic process validation, technical investigations, product transfers, and preparation of technical documentation. The position serves as a key technical interface across internal sites, external partners, Development (SDC), and ESO to enable reliable sterile product supply and compliance. Job Description 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, and customer complaints. Technical Interface & External Supplier Support Act as a technical point of contact between sterile manufacturing sites, CMOs, and Global MS&T for assigned products/processes. Support evaluation of sterile process technologies, equipment compatibility, and aseptic system design requirements. Support ESO during due‑diligence evaluations of sterile external suppliers, including review of facility design, utilities, and compliance with regulatory guidelines. Ensure technical documentation required for risk assessments and supplier qualification is complete, accurate, and audit‑ready. Product Transfers Serve as a technical contributor during sterile product transfers involving legacy or new development products. Support transfers from Development to sterile commercial sites, internal‑to‑internal site transfers, and transfers to external sterile CMOs. Align with Development teams on process design, aseptic requirements, and equipment suitability during early‑stage development. Ensure readiness and completeness of sterile transfer documentation (BMR/BPR, aseptic process descriptions, control strategies, sterilization parameters) Sterile Qualification & Validation (Greenfield & Brownfield) Support qualification of sterile equipment and utilities, including URS review, FAT/SAT, commissioning, and IQ/OQ/PQ execution. Assist in facility and cleanroom qualification activities such as HVAC performance, airflow, pressure mapping, and EM setup. Contribute to validation of sterile processes and systems including media fills, sterilization cycles, autoclaves, SIP, WFI, PW, and clean steam. Support integration, testing, and troubleshooting of equipment and utilities within site IT/automation systems (SCADA/BMS/EMS/MES). Prepare and review essential qualification/validation documents—protocols, reports, risk assessments—ensuring readiness for audits and site start‑up. Cross‑Functional Collaboration & Knowledge Management Support timely knowledge transfer related to sterile manufacturing, aseptic techniques, and contamination control across functional partners. Contribute to standardization and sharing of best practices, technical learnings, and aseptic/sterile process know‑how across MS&T. Lifecycle Management Support assessment and implementation of alternate suppliers for sterile consumables, components, or critical materials. Contribute to sterile process optimization or reformulation activities where applicable. Perform risk assessments related to sterile process improvement, contamination control, and compliance. Provide additional technical support as required for business continuity and audit readiness Provide necessary technical support for tactical or strategic initiatives beyond listed responsibilities as required. Ensure timely completion of compliance activities per organizational and P&O requirements. Adhere to internal governance processes and contribute to continuous improvement of inbound- out bound MS&T practices. What you’ll bring to the role: Essential Requirements: Bachelors/Masters. in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Chemistry or equivalent scientific degree. Desirable MSc. or PhD. Fluent in English & Local Language of the respective Country. Minimum 8 years of experience in pharmaceutical (chemical) manufacturing. Experience in a global/matrix environment in the pharmaceutical industry Comprehensive know how in pharmaceutical (chemical) technology Project Management experience Drug Development experience Sound experience of data handling and applied statistics Why Sandoz? Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. #Sandoz Skills Desired Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer