Process Engineer - NPI- BioPharma

EFOR (formerly Process Engineering Specialists); Singapore; On-site; SGD 60,000 - 95,000; Full time

Job summary

PES is seeking a Process Engineer to support introduction, qualification and commercialization of new products within the Singapore facility. You will ensure production readiness through process assessment, material planning, system setup, and manufacturing execution support while maintaining quality compliance.

Key responsibilities include factory fit assessments, PQ coordination, MES configuration, and cross-functional collaboration with Quality, Supply Chain, and Production teams to enable

Qualifications

• Experience in assessing manufacturing feasibility and process capabilities.
• Familiarity with PQ activities and qualification documentation.
• Ability to coordinate with Quality, Supply Chain, Production and Engineering teams.

Responsibilities

• Assess manufacturing feasibility and readiness for new products in Singapore.
• Coordinate PQ activities and ensure material availability for qualification and startup.
• Create and manage production instructions and BOMs to support manufacturing.
• Configure and troubleshoot MES, verify master data and process routes.
• Collaborate with Quality, Supply Chain, Production, Engineering and Regulatory teams during product transfers and launches.

Skills

Process engineering

Manufacturing readiness

Quality & regulatory

Cross-functional collaboration

Tools

MES

Job description

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

The Process Engineer is responsible for supporting the introduction, qualification, and commercialization of new products and processes within the manufacturing facility. This role ensures production readiness through process assessment, material planning, system setup, and manufacturing execution support, while maintaining compliance with quality and operational requirements.

Key Attributes/Responsibilities

Process Assessment & Manufacturing Readiness

• Assess QC buffer requirements and manufacturing feasibility for products to be produced in Singapore.
• Evaluate process capabilities, equipment suitability, and manufacturing constraints to support local production implementation.
• Perform Facility Fit Assessments (FFA) to ensure product and process compatibility with existing manufacturing infrastructure.

Process Qualification (PQ) Support

• Coordinate and support Process Qualification (PQ) activities to ensure manufacturing readiness.
• Raise requests for raw materials required for qualification runs and production startup.
• Ensure proper segregation, identification, and management of raw materials in accordance with quality and regulatory requirements.
• Work closely with Supply Chain, Warehouse, Quality, and Production teams to ensure material availability for qualification activities.

Manufacturing Documentation Development

• Create and maintain Production Instructions (PIs) to support manufacturing operations.
• Develop and manage Bills of Materials (BOMs) to ensure accurate material planning and production execution.
• Review documentation accuracy and alignment with product specifications and manufacturing requirements.

MES & System Implementation

• Configure and set up products, processes, and workflows within the Manufacturing Execution System (MES).
• Verify MES master data, process routes, and system parameters to support production and qualification activities.
• Troubleshoot and resolve MES-related issues during implementation and startup phases.

Cross-Functional Collaboration

• Collaborate with Quality, Supply Chain, Production, Engineering, and Regulatory teams to ensure smooth product transfers and launches.
• Support investigations, change controls, and continuous improvement initiatives related to manufacturing processes.
• Participate in project meetings and provide technical expertise during product introduction activities.

We are currently looking for candidates in Singapore.