Senior / Manufacturing Engineer, Upstream Processing (USP)

Senior / Manufacturing Engineer, Upstream Processing (USP)
• Own and investigate operation related deviations, RCAs, CAPAs, QE’s
• Act as first line of defense for operation related troubleshooting and recommending corrections
• Set up and ensure that routine manufacturing administration and work processes are effective
• Author/ reviewer for manufacturing related documents e.g. BRs, SOPs.
• Collaborate with MST on technical studies.
• Operations and process monitoring, trending and optimization
• Assess and support equipment/area modifications for operability
• Production capacity analysis and production mapping
• Support the acquiring and implementation of new PU equipment and systems.
• Attend to production emergencies.
• Actively support internal or external audit as manufacturing representatives.
• Support cost reduction or yield/productivity improvement projects related to operations as needed.
• Fulfill project timelines for the Capex and NPI Project
– Map the manufacturing workflow and batch progression to identify critical activities.
– Provide operations / user input to facility, equipment design and software/recipes development.
– Work with MS&T to define raw materials and consumables
– Provide inputs in SAP MM setup.
• Act as Manufacturing single point of contact for Technology Transfer work streams
• Develop and conduct training for Manufacturing Biotechnologists and junior staff
• Participate as manufacturing representative in site wide optimization and improvement project i.e. CIP improvement project.
• Ensure adherence to production plan
• Cross-functional coordination with Site Engineering, SCM, MS&T, etc.
• Support change control • Adherence to any applicable HSE and Quality Compliance requirements
• Degree in Biotechnology, Biochemistry, or related discipline
• Must have experience with production scale equipment such as stainless steel tanks, bioreactors, control systems (e.g. DeltaV or other SCADA, etc.)
• At least 4 to 6 years' experience with cell culture or other biotech processes is required.
• Able to coach and train organization on Operational Excellence tools/Methodologies.
• 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.
Novartis Technical Operations
Technical Operations
Full Time