Process Development Engineer - API Manufacturing

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Nusantara Prime Consulting Pte. Ltd. in Singapore seeks a Process Engineer to lead API manufacturing process development, optimization, and scale-up, collaborating with R&D, QA, QC and regulatory teams.

You will conduct root cause analysis, implement CAPA, author batch records, SOPs and validation reports, and support technology transfer from development to commercial-scale production. Additionally, perform DoE and FMEA, monitor process data with statistics, and train manufacturing staff.

Qualifications

• Diploma or bachelor’s degree in engineering or related field.
• 1–4 years of relevant work experience.
• Experience in API manufacturing is a plus.

Responsibilities

• Lead process development, optimization, and scale-up for API manufacturing.
• Conduct root cause analysis and implement CAPA for deviations and yield losses.
• Author and review batch records, SOPs, validation protocols, and technical reports.
• Collaborate with R&D, QA, QC, and regulatory affairs to ensure process compliance.
• Support technology transfer from development to commercial-scale manufacturing.
• Perform process risk assessments (FMEA) and design of experiments (DoE).
• Monitor and analyze process performance data using statistical tools.
• Provide technical guidance and training to manufacturing operators and technicians.

Skills

Process development

CAPA

DoE

FMEA

Statistical analysis

Education

Diploma or Bachelor's degree in engineering

Job description

Nusantara Prime Consulting Pte. Ltd. in Singapore seeks a Process Engineer to lead API manufacturing process development, optimization, and scale-up, collaborating with R&D, QA, QC and regulatory teams.

You will conduct root cause analysis, implement CAPA, author batch records, SOPs and validation reports, and support technology transfer from development to commercial-scale production. Additionally, perform DoE and FMEA, monitor process data with statistics, and train manufacturing staff.