Manufacturing Engineer (Deviations)

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

ANTAES ASIA PTE. LTD. is looking for candidates to contribute to Life Science projects. Responsibilities include leading complex technical investigations, utilizing Root Cause Analysis tools, authoring comprehensive reports for audits, and performing impact assessments on product quality. Applicants will collaborate with QA and Production teams, implement Corrective and Preventive Actions (CAPAs), and participate in drafting SOPs. This role requires proactive engagement in promoting Antaes services in Singapore.

Responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Lead technical investigations into manufacturing deviations.
• Utilize Root Cause Analysis tools to identify triggers.
• Author comprehensive investigation reports for audits.
• Perform impact assessments on product quality and safety.
• Design and implement Corrective and Preventive Actions.
• Monitor effectiveness of implemented CAPAs.
• Identify trends in manufacturing data for improvements.
• Provide real-time support for troubleshooting.
• Collaborate with QA and Production teams.
• Participate in drafting SOPs and Validation protocols.
• Promote Antaes services alongside client assistance.

Job description

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
• 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