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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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