Manufacturing Engineer (Deviations)

Job Description:

• 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.
• Collaborate with Quality Assurance (QA) and Production teams to ensure all activities align with Standard Operating Procedures (SOPs).
• Participate in the drafting and revision of SOPs, Batch Records, and Validation protocols.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
• 2 years’ experience in Engineering, pharmaceutical industry
• Proven track record in managing the full lifecycle of a deviation
• Deep understanding of 21 CFR Part 210/211 and Annex 11/15
• Adherence to safety protocols and global regulatory compliance
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills