Process Engineer/Process Owner
Date Posted: December 15, 2025
Job Description
The Process Engineer / Process Owner drives the critical migration from SAP to MES for a major manufacturing project. In this role, you act as the primary advocate for the Production team, ensuring that system designs reflect real-world operational needs. You take full ownership of buffer preparation processes while bridging the gap between Production, Design, and Automation. Your expertise ensures that process requirements translate perfectly into automation solutions while you maintain strict GMP compliance and data integrity.
Key Responsibilities
- Drive Process Ownership for buffer preparation, representing production needs from project kickoff through to final implementation.
- Lead the SAP–MES Migration as the primary interface, ensuring that operational workflows and manufacturing intents are accurately captured in the new system.
- Master URS Development by leading reviews to align system specifications with the practical requirements of the production floor.
- Bridge Technical Interfaces by collaborating with Design and Automation teams to verify that functional specifications match process workflows.
- Manage Change Control activities, assessing the impact of process changes and supporting implementation within a live GMP environment.
- Execute Protocol Reviews for FAT, SAT, IQ/OQ, and UAT, ensuring all MES-related changes meet validation standards.
- Champion GMP Compliance by reviewing deviations and risk assessments to safeguard data integrity and quality standards.
- Coordinate Stakeholders across IT, Engineering, and Quality to align on project timelines, mitigate risks, and resolve issues.
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.
- Hands-on experience acting as a process owner or production representative for large-scale system implementations.
- Strong experience with URS development, process design reviews, and validation-related activities.
- Exposure to MES systems (such as PAS-X or Syncade) and SAP within a manufacturing context.
- Solid understanding of GMP manufacturing and data integrity requirements.
- Excel at stakeholder management, with a proven ability to bridge the gap between technical automation 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