Expert- Analytical Instrumentation Engineering

Your responsibilities will include, but are not limited to:

• Inventory management for spares and tracking; Reduction of downtime of instrument for business continuation of organization
• Compliance as per applicable GDP and cGMP Practices. Support the IQ, OQ, PQ, and life cycle management of Laboratory Equipment/instrument as per applicable procedures/guidelines.
• Coordinate with the external vendors and ensure optimum utilization of AMC/CMC/contract.
• Perform the Breakdown maintenance and Preventive maintenance for Agilent 1290HPLC, GC, Sotax Dissolution, Distek Dissolution, and another various analytical instrument.
• Installation, Calibration and Preventive Maintenance of Sotax and Distek Dissolution Apparatus.
• Coordinate with all partners to ensure all relevant tasks are completed as per the agreement.
• Ensure Audit readiness at all times. 4Ensure alignment to all applicable HSE standards and guidelines.
• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.

Key performance indicators:

• As per the defined objectives and goals The critical metrics will include (but not limited to) are Instrument Downtime, Number of IQs/OQs/PQs, Audit observations, Delivery timeliness, Quality of work etc.
• Consistency to quality, quantity and timelines for all work you're leading.
• No deviations while implementing tasks of relevant area.
• No human error during task accomplishment and/or review under area of work.
• Zero data integrity incident.
• No delay in agreed project timelines due to non-professional execution of analytical tasks, coordination or communication.
• No incident in the laboratory occurred.
• Full ownership of assigned instrumentation, laboratory environment and related duties.
• Consistency to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
• Ensures reproducibility of experiments and results.
• Refer to annual individual and team objective setting.

Minimum Requirements:

·7-12 Years of experience in analytical lab instrument service management and preventive maintenance for different makes and types of instrument

·Hands on experience and knowledge over the GDP and cGMP Practices

·Experience over the IQ, OQ, PQ, and life cycle management of Laboratory

·Equipment/instrument.

·Experience over the external vendor management. Optimum utilization of

·AMC/CMC/contract.

·Experience software qualification and guideline GAMP5, 21CFR, Annex-11,

·EDQM etc.

·Sound experience of inter department coordination.

·Sound technical communication.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we

achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network