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Manufacturing Engineer (Deviations)

Company

ANTAES ASIA PTE. LTD.

Location

singapore, singapore

Type

Full-time

Responsibilities
  • Contribute to Life Science projects for Antaes Asia clients
  • Lead complex technical investigations into manufacturing deviations, non-conformances, and environmental excursions
  • Utilize structured Root Cause Analysis (RCA) tools (e.g., Fishbone, 5 Whys, FMEA) to identify underlying triggers
  • Author comprehensive investigation reports that withstand rigorous internal and external regulatory audits (FDA, EMA, etc.)
  • Perform impact assessments on product quality, safety, and efficacy
  • Design and implement Corrective and Preventive Actions (CAPAs) to eliminate recurrence of deviations
  • Monitor the effectiveness of implemented CAPAs through data-driven metrics
  • Identify trends in manufacturing data to proactively suggest process improvements and Right First Time (RFT) initiatives
  • Provide real-time engineering floor support to troubleshoot equipment malfunctions or process drift
  • <...

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