Process Engineers - Singapore at Advanced Manufacturing Tech Solutions (AMTSOL)

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

19 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Engineering, GMP, GxP, Process Validation, Technology Transfer, Root Cause Analysis, Lean, Six Sigma, Kaizen, SOPs, Batch Records, FMEA, CQV, Data Integrity, EHS, Process Optimization

Industry

Pharmaceutical Manufacturing

Description

Job Title: Process Engineer Location: Singapore Experience: 8 years Industry: Pharmaceutical / Biotech / Medical Devices Job Summary We are seeking a qualified Process Engineer to support the design, development, optimization, and validation of manufacturing processes in a regulated GMP environment. The role involves close collaboration with cross‑functional teams to ensure safe, compliant, efficient, and robust manufacturing operations while driving continuous improvement initiatives. Key Responsibilities Design, develop, and optimize manufacturing processes for pharmaceutical, biotech, or medical device production Support technology transfer, process validation, and scale‑up activities from development to commercial manufacturing Ensure all processes comply with GMP, GxP, EHS, and data integrity requirements Lead or support process troubleshooting, deviation investigations, and root cause analysis (RCA) Drive continuous improvement initiatives using Lean, Six Sigma, and Kaizen methodologies Prepare, review, and maintain process documentation including SOPs, Batch Records, URS, PFDs, and P&IDs Collaborate with Quality, Production, Automation, Maintenance, Engineering, and Validation teams Support CAPA implementation, change control, and risk management activities (FMEA) Participate in Commissioning, Qualification, and Validation (CQV) activities Analyze process and manufacturing data to improve yield, efficiency, and product quality Support regulatory inspections, audits, and internal quality reviews as required Required Qualifications Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related field 8 years of experience in a GMP-regulated manufacturing environment Strong understanding of pharmaceutical / medical device manufacturing processes Hands-on experience with process validation, tech transfer, and deviation management Working knowledge of GMP, GxP, EHS, and data integrity guidelines Experience with process risk assessment tools such as FMEA Ability to work cross‑functionally and communicate effectively with stakeholders Preferred Skills & Experience Exposure to automation systems (DCS, PLC, SCADA, MES) Knowledge of CQV lifecycle and validation documentation Lean Six Sigma certification (Green Belt/Black Belt) Experience supporting regulatory inspections (FDA, EMA, MHRA, etc.) Strong analytical, problem‑solving, and documentation skills Key Competencies Process optimization and troubleshooting Quality and compliance mindset Data‑driven decision making Cross‑functional collaboration Continuous improvement orientation

Responsibilities

The Process Engineer will design, develop, and optimize manufacturing processes within a regulated GMP environment to ensure efficiency and compliance. They will also lead troubleshooting, continuous improvement initiatives, and cross-functional collaboration to support technology transfer and validation activities.