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Senior Process Engineer, MSAT

Senior Process Engineer, MSAT

LONZA BIOLOGICS TUAS PTE. LTD.Singapore, Pedra Branca, Singapore
24 days ago
Job description

Key responsibilities :

Technology Transfer

  • Support the timely and successful transfer of the customer's manufacturing process into the Lonza Singapore production facility. Work with other team members to support technology transfer
  • Perform / support experiments in the MSAT scale-down process lab to support process technology transfer. Follow all applicable lab safety policies.
  • Provide floor and on-call support for projects being transferred
  • Work closely with customers to identify and resolve tech transfer gaps and process issues
  • Write master batch records and develop operator training packages
  • Deliver pre-campaign training and perform post-campaign reviews of assigned processes.
  • Support investigations into process issues or deviations, write minor / major deviations are assigned.

Process Support

  • Support / lead pre-campaign preparation activities (BR review, training, change requests) for assigned projects per pre-defined schedule
  • Provide floor and on-call support during production. Escalate issues to management appropriately and interface with customer on issue resolution
  • Compile and disseminated daily process updates
  • Ensure presence on the floor to support production and MSAT review of operations
  • Support investigations into process issues or deviations, write minor / major deviations
  • Support / lead the investigation into process trends to support process monitoring requirements, support preparation of APR and CPV reports, perform work-stages to support customer BLA filing
  • Keep current appropriate databases with MFG process data and analyze to monitor run to run consistency for manufacturing operations and identify opportunities for improvement.
  • Support inspections and audits by customer and regulatory authorities as required
  • Any other duties as assigned by your Supervisor / Manager.

    • Key requirements :

  • Degree in Chemical Engineering, Biochemical Engineering, Biochemistry / Chemistry / Microbiology or related discipline.
  • Exposure in Biotechnology process development, process support, research or a related manufacturing environment is desirable.
  • Prior hands-on technical experience (in a laboratory or manufacturing environment) is desirable.
  • Knowledge of Excel as well as Statistical Data Analysis tools.
  • Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.
  • Excellent technical writing skills, ability to provide attention to detail is essential.
  • Demonstrated track record in completing projects under tight timelines.

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    Senior Engineer • Singapore, Pedra Branca, Singapore