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Process Expert

4 weeks ago

Singapore Novartis Farmacéutica Full time

The Process Expert for Upstream will be responsible for supporting manufacturing with technical knowledge within a defined discipline of Upstream operations including mammalian cell culture, harvest, seed train operation, etc.
About the Role
Key responsibilities:
Attend to production emergencies and act as first line of defense for operation-related troubleshooting and recommending corrections.
Set up and ensure that routine manufacturing processes are effective and efficient.
Attend to any quality incident and act as deviation investigation owner/CAPA owner as required.
Author/reviewer for manufacturing related documents e.g. BRs, SOPs.
Conduct operations and process monitoring, trending, and optimization.
Support cost reduction or yield/productivity improvement projects related to operations as needed.
Support change control by owning or leading MU related actions.
Actively support internal or external audit as Manufacturing representatives.
Provide operations/user input/assessment and support equipment/area/system/facility modifications or acquisitions related to MU.
Provide inputs in SAP MM setup.
Minimum Qualifications:
Minimum Bachelor degree in Chemical, Mechanical Engineering, Biotechnology or Life Sciences.
Minimum 3 years of experience in commercial manufacturing biotechnology processes i.e. cell culture is required.
Must have an understanding of pharmaceutical industry trends and practices.
Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and qualification and validation required.
Must have experience with production scale equipment such as stainless steel tanks, bioreactors, centrifuges, filtration systems, control systems (e.g. DCS or other SCADA, etc.) and CIP/SIP systems.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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