Process Engineer / Process Owner
Date Posted: December 15, 2025
Job Description
The Process Engineer / Process Owner will support a key manufacturing project focused on the migration from SAP to MES, acting as the primary representative of the Production team. The role includes full ownership of buffer preparation processes and close involvement in URS development, system design reviews, change management, and protocol execution.
This position sits at the interface between Production, Design, and Automation, ensuring process requirements are correctly translated into system and automation solutions while maintaining GMP compliance. Strong stakeholder management and communication skills are critical to success in this role.
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.
Required Qualifications and Skills
- 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.
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