Process Engineer – DSM Upstream & Downstream

About the role

You will join the Drug Substance Manufacturing (DSM) team to provide technical support, optimization, and lifecycle management for both upstream and downstream biopharmaceutical processes. The role ensures reliable, compliant, and efficient operation of manufacturing systems that produce life‑changing biologic medicines.

Key responsibilities

• Provide day‑to‑day engineering support for upstream (cell culture, bioreactor, harvest) and downstream (filtration, chromatography, viral inactivation, ultrafiltration/diafiltration) operations.
• Monitor performance, identify optimization opportunities, and drive capacity enhancements.
• Lead investigations of process deviations, quality events, out‑of‑trend results, and manufacturing issues; perform root‑cause analysis and implement CAPAs.
• Own and execute process changes through the site change‑control system.
• Support process validation, characterization studies, technology transfers, and continuous process verification.
• Develop and improve SOPs, risk assessments, engineering studies, and technical reports.
• Collaborate with Manufacturing, MSAT, Quality, Validation, Automation, and Engineering teams.
• Participate in equipment and process design reviews, qualification, and commissioning activities.
• Analyze manufacturing data to drive operational excellence and support audits.

Required profile

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Engineering, or a related discipline.
• Experience in biopharmaceutical manufacturing, process engineering, MSAT, or technical operations.
• Knowledge of GMP regulations and pharmaceutical quality systems.
• Proven ability to work in cross‑functional teams in a fast‑paced environment.

Required skills

• GMP compliance and regulatory knowledge
• Cell culture and bioreactor operation
• Filtration, chromatography, viral inactivation, ultrafiltration/diafiltration
• Process monitoring and statistical analysis
• Deviation investigation, change control, CAPA, risk assessment
• Process validation, technology transfer, continuous process verification
• Equipment qualification and commissioning