Process Engineer

Job Description

The Process Engineer / Process Owner drives the critical migration from SAP to MES for a major manufacturing project, acting as the primary advocate for the Production team. In this role, you take full ownership of buffer preparation processes while ensuring that design and automation solutions align perfectly with operational reality. You sit at the vital interface of Production, Design, and Automation, translating complex process requirements into functional system solutions within a strict GMP environment.

Key Responsibilities

• Drive Process Ownership for buffer preparation, ensuring all manufacturing workflows and operational needs remain central to the project lifecycle.
• Lead the SAP–MES Migration as the primary production interface, ensuring the new system enhances rather than hinders manufacturing efficiency.
• Author and Review URS (User Requirements Specifications) to ensure technical teams capture production requirements accurately from the start.
• Bridge Design and Automation by working closely with engineering teams to review functional specifications and system designs.
• Manage Change Control activities, performing rigorous impact assessments to support system implementation in a live GMP environment.
• Execute Protocol Reviews for FAT, SAT, IQ/OQ, and UAT, providing the technical oversight needed for successful system handover.
• Ensure GMP Compliance and data integrity by reviewing process-related deviations, risk assessments, and internal quality standards.
• Coordinate Stakeholders across IT, Engineering, Quality, and Operations to align on project timelines, risks, and strategic decisions.

Required Qualifications and Skills

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline.
• 5+ years of experience in process engineering or manufacturing support within a pharmaceutical or biologics environment.
• Demonstrate a history of acting as a Process Owner or Production Lead for large-scale system implementations.
• Exposure to MES platforms (such as PAS-X or Syncade) and SAP within a manufacturing context.
• Strong experience in URS development, process design reviews, and validation-related activities.
• Solid understanding of GMP manufacturing standards and data integrity requirements.
• Excel at bridging the gap between technical automation teams and operational production staff.
• Apply analytical thinking to resolve issues during commissioning, verification, and system migration phases.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E