Manufacturing Engineer, Shared Functions

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics) - 8 Tuas Bay Lane Singapore

Job Purpose
Responsible for supporting manufacturing with technical knowledge within a defined discipline of Weighing and Dispensing of raw materials and Media/Buffer Preparation.
 
Key Responsibilities
  • Attend to production emergencies and act as first line of defence for operation related troubleshooting and recommending corrective actions.
  • Set up and ensure that routine manufacturing administration and work processes are effective and efficient.
  • Act as author / reviewer for manufacturing related documents e.g. batch records, SOPs
  • Perform production capacity analysis and production mapping 
  • Conduct operations and process monitoring, trending and optimization
  • Support cost reduction or yield / productivity improvement projects related to operations as needed.
  • Participate as manufacturing representative in site wide optimization and improvement project
  • Support change control by owning or leading PU related activities
  • Actively support internal or external audit as manufacturing representatives
  • Provide operations / user input to facility, equipment design and software / recipes development
  • Assess and support equipment/area/ system modifications or acquisitions related to PU
  • Work with MS&T on technical studies, including identification of raw materials and consumables
  • Provide inputs to SAP MM set up
  • Develop and conduct training and mentorship for Manufacturing Biotechnologists
  • Cross-functional coordination with Site Engineering, SCM, MS&T, etc.
  • Adherence to any applicable HSE and Quality Compliance requirements
 
Requirements
  • Degree in Chemical, Mechanical Engineering, Biotechnology or Life Sciences is required
  • Minimum 4 years' experience with cell culture or other biotech processes like protein refolding and protein purification 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, chromatography systems, control systems (e.g. DCS or other SCADA, etc.) and CIP/SIP systems
 


Post Date 14 December 2017
End Date 28 December 2017

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Company Profile

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. (Biologics)

Singapore - West - Tuas

Novartis BioProduction Operations Singapore is a new entrant to the Singapore biologics sector. Our facility will focus on drug substance manufacturing based on cell culture technology. The site is designed to handle small and large scale volumes to support both clinical and commercial production of potential new products.