Process Engineer

About the Role

We are seeking a Process Engineer to support manufacturing operations within a leading biopharmaceutical facility. The successful candidate will work closely with cross-functional teams to ensure reliable, compliant, and efficient manufacturing processes while driving continuous improvement initiatives.

Key Responsibilities

• Provide day-to-day engineering support for manufacturing operations.
• Support process optimization, troubleshooting, and root cause investigations to improve process reliability and performance.
• Work closely with Manufacturing, Quality, Validation, and Maintenance teams to resolve process-related issues.
• Assist in process monitoring, data analysis, and implementation of continuous improvement initiatives.
• Support equipment qualification, process validation, and change control activities where required.
• Ensure all engineering activities are carried out in compliance with GMP, safety, and regulatory requirements.
• Provide engineering support for downstream processing equipment, including chromatography skids and ultrafiltration/diafiltration (UF/DF) systems, ensuring reliable operation, troubleshooting, and process optimization.
• Prepare and maintain technical documentation, SOPs, engineering reports, and deviation investigations.
• Participate in project activities related to process improvements, equipment upgrades, and technology transfer.

Requirements

• Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related engineering discipline.
• Experience within the biopharmaceutical or pharmaceutical manufacturing industry.
• Experience supporting upstream and/or downstream manufacturing processes, with downstream processing experience preferred.
• Hands-on experience with downstream biotechnology equipment such as chromatography skids and ultrafiltration/diafiltration (UF/DF) systems is highly preferred.
• Hands-on experience with DeltaV DCS is highly preferred.
• Familiarity with GMP regulations and regulated manufacturing environments.
• Strong analytical and problem-solving skills with the ability to work collaboratively across multiple functions.
• Excellent communication and stakeholder management skills.

Preferred Experience

• Biologics manufacturing experience.
• Exposure to process validation, CAPA, deviation investigations, and change controls.
• Experience supporting continuous improvement initiatives and process optimization projects.