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