Bioprocess Engineer DSP

What you will do:

• Lead and oversee DSP manufacturing campaigns, ensuring execution, monitoring, troubleshooting, and documentation are compliant with cGMP and regulatory requirements.
• Act as the manufacturing Functional Lead for assigned products, coordinating cross-functional teams and maintaining technical expertise in processes, equipment, and facilities.
• Drive risk management activities, including SHE, EM, operational, cleaning, and product risk assessments, while supporting investigations, deviations, CAPAs, and change controls.
• Maintain GMP documentation such as SOPs, manufacturing instructions, risk assessments, and records to ensure compliance and audit readiness.
• Train and support manufacturing personnel, contributing to workforce development and fostering a culture of safety, quality, operational excellence, and continuous improvement.
• Represent manufacturing in capital projects, providing technical input for facility design, equipment selection, commissioning, qualification, and technology transfers.
• Lead continuous improvement initiatives and serve as a manufacturing representative during customer audits, inspections, and strategic cross-functional projects.
• What we are looking for:
• Strong expertise in biopharmaceutical manufacturing, particularly downstream processing (DSP), with the ability to troubleshoot technical and process-related issues.
• Solid understanding of cGMP requirements and regulatory standards applicable to pharmaceutical manufacturing.
• Experience managing quality systems and compliance activities, including risk assessments, deviations, CAPAs, change controls, and validation.
• Proven problem-solving skills with the ability to identify root causes and implement effective corrective actions.
• Strong communication and stakeholder management capabilities, enabling effective collaboration across functions and organizational levels.
• Demonstrated project leadership and team coordination experience within complex, regulated manufacturing environments.
• Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related field, along with relevant experience in biopharmaceutical manufacturing, process engineering, technical operations, or cGMP-regulated environments.