Process Engineer

Position Overview

The Process Engineer serves as process owner for manufacturing equipment and systems at a biologics manufacturing site, applying engineering principles to improve performance, reliability and cost-effectiveness. The role combines process support, contamination control and inspection readiness, working closely with Manufacturing, Engineering, Utilities, Maintenance, Quality Assurance and Validation. The Process Engineer leads deviation investigations, manages change controls and equipment qualification activities, and supports the introduction of advanced Next Generation Manufacturing technologies. The role also supports regulatory inspections as a subject matter expert and provides on-call support.

Key Responsibilities

• Recommend, design and implement new equipment or system modifications using engineering principles
• Partner with cross-functional teams to implement operational improvements and ensure reliable, cost-effective process systems
• Troubleshoot and resolve equipment, automation and process issues of simple to moderate complexity, and provide technical support to commercial manufacturing
• Help introduce advanced Next Generation Manufacturing technologies into the plant
• Lead root cause analysis for major deviations, and develop and implement corrective and preventive actions (CAPA)
• Initiate and manage change controls of moderate to complex scope, including continuous improvement and productivity initiatives
• Manage changes associated with process equipment commissioning, qualification and validation
• Prepare, analyse and present results and complex information at cross-functional meetings, teleconferences and management reviews
• Support the site contamination control program by owning deviations, leading low-to-moderate complexity investigations and supporting complex ones
• Maintain contamination control dashboards, metrics and trackers, and support cleanroom procedures, gowning practices and environmental monitoring deliverables
• Coordinate with the environmental monitoring sampling team and area owners to ensure sampling readiness and timely closure of observations
• Prepare inspection materials such as storyboards, evidence binders and pressure test packages, and support the triage room during regulatory inspections
• Act as SME to present deviations, CAPA and change control records during inspections, and follow up promptly on inspection requests and observations
• Review batch records and documentation, and identify digitalisation opportunities to improve deviation, CAPA and change control processes

Required Qualifications

• Bachelor's degree in Engineering (Chemical, Biochemical, Mechanical or a related discipline) or a related science field
• 4 to 7 years of relevant experience in a biologics, biotechnology or pharmaceutical manufacturing environment
• Working knowledge of cGMP and experience in a regulated environment
• Experience leading deviation investigations and root cause analysis, and developing and implementing CAPA
• Experience initiating and managing change controls of moderate to complex scope
• Familiarity with equipment commissioning, qualification and validation
• Ability to troubleshoot equipment, automation and process issues in the field
• Knowledge of contamination control, cleanroom practices and environmental monitoring programmes
• Experience supporting regulatory inspections, including presenting records as a subject matter expert
• Strong data analysis, technical writing and presentation skills, with the ability to communicate with cross-functional teams and management
• Ability to work independently, prioritise multiple tasks and provide on-call support