Purpose & Scope
Reporting directly to the Operations Engineering Lead, the Process / Tech Transfer Engineer provides critical technical and engineering support to the manufacturing and operations teams. This role bridges the gap between development and commercial manufacturing, ensuring the seamless scale-up, validation, and implementation of new drug manufacturing processes and technologies.
Additionally, you will support process control systems and process optimization, while maintaining strict compliance with cGMP, safety, and environmental standards.
Roles and Responsibilities
Technology Transfer: Lead and support the technical transfer, scale-up, and commissioning of new manufacturing processes, equipment, and new product introductions (NPI) to the sit
Process Engineering Support: Provide daily technical support to operations, ensuring manufacturing schedules are met and automated equipment runs at peak performance
System Compliance & Control: Take responsibility for the Distributed Control Systems (DCS) and Programmable Logic Controllers (PLC) within assigned production areas, ensuring data integrity and system reliability
Troubleshooting & Investigations: Lead root-cause analysis (RCA) for complex process deviations and equipment technical issues, establishing robust long‑term technical solutions
CAPA Management: Track, manage, and expedite the execution of Corrective and Preventive Actions (CAPAs) and Change Controls related to operations and process systems
Continuous Improvement: Coordinate Lean initiatives to drive process optimization, yield improvements, waste reduction, and energy‑saving programs
Regulatory Compliance: Ensure all engineering and tech transfer activities comply with cGMP, FDA, EMA, Health & Safety legislation, and environmental standards
Required Qualifications & Experience
Education: Bachelor’s degree (B.Sc./B.Eng.) in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, or an equivalent technical discipline
Experience: 3+ years of process engineering or technology transfer experience within a highly regulated manufacturing environment (Pharmaceutical, Medical Device, or Biotech preferred
Technical Proficiency: A broad understanding of core pharma/biotech unit operations (e.g., filtration, purification, formulation, lyophilization, or fill‑finish technologies) along with exposure to process validation
Analytical Skills: Proven problem‑solving capabilities, ideally supported by a Lean Six Sigma belt or equivalent continuous improvement expertise
Project Mindset: Demonstrated ability to manage projects independently, develop technical specifications, and assist with commissioning/handover protocols
Preferred Qualifications
Direct experience in commercial drug substance or drug product manufacturing
Familiarity with cGMP start‑up, tech transfer sequencing, or facility expansion environments
Hands‑on experience configuring or working with automated process control systems (e.g., Emerson DeltaV, Siemens, or similar platforms)
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