Process Development Senior Engineer

Job Summary:

The Senior Process Development Engineer will provide experienced scientific and process engineering support for new product introduction (NPI)/ technology transfer and commercial biologics manufacturing.

The role will independently execute assigned NPI and technology transfer workstreams while providing senior technical guidance to the commercial Process Development team in the areas of complex investigations, process troubleshooting, campaign readiness, cross-network technical alignment, and continuous improvement.

The successful candidate will apply strong biologics process knowledge, manufacturing experience and scientific judgment to assess process performance, identify technical risks, develop evidence based recommendations and support effective resolution of manufacturing issues.

This position will operate within the established Process Development and technology-transfer governance structure. The role is not expected to serve as the formal Technology Transfer Lead but will provide experienced technical leadership for assigned workstreams and escalate key decisions through the designated Technology Transfer Lead and Process Development leadership.

Main Responsibilities:

• Independently lead assigned NPI and technology-transfer technical workstreams, including process knowledge transfer, facility/process fit assessment, technical documentation and risk identification.
• Translate process characterization, scale-up and manufacturing knowledge into ASM requirements and support readiness for engineering runs and PPQ.
• Identify technical gaps and risks, develop recommendations and mitigation options, and escalate key decisions through the designated Technology Transfer Lead and PD leadership.
• Provide scientific and engineering support to the commercial PD team for cell culture, harvest and/or purification processes.
• Evaluate manufacturing performance and complex process issues using process knowledge, historical experience and engineering principles to develop technically sound recommendations.
• Partner with Manufacturing, Quality and other technical functions to resolve process challenges and support reliable commercial manufacturing.
• Lead or provide senior technical guidance for complex deviation investigations, including hypothesis development, data assessment, root cause evaluation and technical impact assessment.
• Integrate process, equipment, manufacturing and historical data to develop scientifically justified conclusions and risk-based recommendations.
• Coach PD engineers in structured problem solving, investigation strategy and clear technical communication to Manufacturing, Quality and leadership.
• Any other tasks as assigned by the supervisors.

About You:

• Master’s Degree and 4 years of directly related experience OR Bachelor’s / Advanced Degree in Engineering, Science or related technological field and 6+ years of directly related experience.
• 6+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries.
• At least 4 years’ experience with regulated environments (i.e. cGMP) required.
• In depth cell culture and/or purification process knowledge, including single-use technologies and harvest technologies.
• Good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale.
• Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production.
• Experienced in Technology Transfer of new process and technology to commercial site.
• Strong communication skills (technical writing and verbal communication/presentation).
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approaches.
• Familiarity with documentation in a highly regulated environment.
• Ability to independently determine when additional resources are required to solve problems.
• Ability to provide solutions to a large variety of technical problems.
• Able to lead small team and lead projects.

Contract Duration: 12 Months