Process Engineer

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.