Process Engineer

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 75,000 - 95,000; Full time

Job summary

A consultancy firm based in Singapore is seeking a Process Owner with over 5 years of experience in process engineering within the pharmaceutical sector. Responsibilities include acting as the primary production interface for SAP-MES migrations, leading URS development, and ensuring compliance with GMP standards. Candidates should have a Bachelor’s degree in a relevant field and possess strong communication skills to coordinate between various stakeholders. This role offers a critical position in a dynamic environment.

Qualifications

• 5+ years of experience in process engineering or manufacturing support in pharmaceuticals.
• Experience acting as process owner for projects or system implementations.
• Strong understanding of GMP manufacturing and data integrity.

Responsibilities

• Act as the Process Owner for buffer preparation in the project lifecycle.
• Lead URS development, ensuring alignment with operational requirements.
• Support change control activities, assessing process impacts.

Skills

Process ownership

Stakeholder management

GMP compliance

Communication skills

Education

Bachelor’s degree in Chemical Engineering

Biochemical Engineering

Biotechnology

Tools

MES systems (e.g. PAS-X, Syncade)

SAP

Job description

Key Responsibilities

Process Ownership & Production Representation

• Act as the Process Owner for buffer preparation, representing production requirements throughout the project lifecycle.

• Serve as the primary production interface for the SAP-MES migration project.

• Ensure process intent, operational workflows, and manufacturing needs are accurately captured and implemented.

URS, Design & Automation Interface

• Lead and contribute to URS development and reviews, ensuring alignment with production and operational requirements.

• Work closely with Design and Automation teams to review system designs, functional specifications, and process workflows.

• Ensure process requirements are correctly translated into MES and automation functionality.

Change Management & GMP Compliance

• Support and manage change control activities, assessing process impact and supporting implementation in a live GMP environment.

• Review and approve process-related changes, deviations, and risk assessments.

• Ensure compliance with GMP, data integrity, and internal quality standards.

Protocol Review & Project Support

• Review and support execution of protocols (FAT, SAT, IQ/OQ, UAT where applicable) related to MES and process changes.

• Provide input into commissioning, verification, and system handover activities.

• Support production readiness and smooth transition during system migration.

Stakeholder Coordination

• Act as the key liaison between Production, Engineering, Automation, IT/MES, Quality, and Project teams.

• Communicate clearly with multiple stakeholders to align on requirements, timelines, risks, and decisions.

• Support project meetings, progress reviews, and issue resolution.
  

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline.

• 5+ years of experience in process engineering or manufacturing support within a pharmaceutical or biologics environment.

• Hands‑on experience acting as process owner or production representative for projects or system implementations.

• Strong experience with URS development, process design reviews, and stakeholder coordination.

• Exposure to MES systems (e.g. PAS-X, Syncade, or equivalent) and/or SAP in manufacturing environments is an advantage.

• Experience supporting change management, protocol reviews, and validation‑related activities.

• Solid understanding of GMP manufacturing and data integrity requirements.

• Strong communication and stakeholder management skills, with the ability to bridge technical and operational teams.