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Open nowPosted 24 days ago

Manufacturing Engineer (Deviations)

MyCareersFuture94,028 open roles

Pay
SGD 4,000 – SGD 6,000 a month
Where
Singapore
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Your applicationOpen nowManufacturing Engineer (Deviations)MyCareersFuture · Singapore

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The clock on this job

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Share of postings closed within
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  2. 3.3%3 days
  3. 7.7%7 days
  4. 14.0%14 days
  5. 33.7%30 days
This job: posted 24 days ago

The posting

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
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