Process Expert

15 hours ago


Tuas, Singapore Novartis Full time

**Summary**:
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 defend 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.

Essential Requirements:

- Minimum Bachelor degree in Chemical, Mechanical Engineering, Biotechnology or Life Sciences
- Fluent in English
- 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.

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

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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