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