Process Engineer III, DSP

Work Schedule

Environmental Conditions

Job Description

Key areas of accountability/responsibility

• Lead (or support as a mentor) and deliver standard MSAT work (both client programs and internal projects) with the goal of being timely, accurate, and customer-centric.
• Represent Thermo Fisher as (support) technical project lead, in customer communications and internal discussions.
• Provide technical and technological expertise to steer decisions in preparation for, during and after manufacturing activities.
• Responsible for/support process validation studies by preparing, coordinating (and completing) studies, ensuring running activities are on track and (supporting) the timely and accurate completion of approved validation reports.
• Monitor project progression, communicate risks timely and seek to resolve challenges, both internally and externally.
• Aid in the enhancement and implementation of efficient procedures, regulatory standards, and novel production processes. Additionally, refine existing practices to improve cost-effectiveness, efficiency, and quality. At times, assume the responsibility of leading site projects during the implementation phase.
• Participate and monitor technological developments in the biopharmaceutical industry and assess their applicability to Thermo Fisher.
• Aim to build and maintain internal and external networks, within defined expertise area.
• Ensure individual trainings are up-to-date and aligned to Thermo Fisher guidelines and systems.
• Represent Thermo Fisher at audits on technology transfer across clinical and commercial phases, implementation of manufacturing processes, validation, and manufacturing problem-solving.
• Collaborate with functional managers to ensure knowledge and skills are collected.
• Available for MSAT after-hours on-call when needed and may be on-site after-hours for fixing critical cases.
• Follows EH&S guidelines and contribute to improvement activities.
• Fulfil other duties as assigned.

Knowledge and educational level

• Recognized university degree in one of the fields related to the production of biopharmaceuticals (E.g. Biochemistry, Biology, Biotechnology, Chemical Engineering, Chemistry).
• Proficient in facility fit assessments, material qualification, process models, scaling from bench scale to large scale, process descriptions, process flow diagrams, equipment automation recipes, process solving, deviation investigations and corrective/preventive actions.
• Has completed process validation plans and studies, process risk assessments, process control strategies, continued process verification reporting, routine process monitoring guidelines, and post-regulatory filing changes.

Required level of experience

• More than 5 years of technology transfer experience in mammalian downstream bioprocessing; or
• More than 8 years of hands-on experience in process development or manufacturing downstream bioprocessing;
• Abilities and experience considered equivalent to the ones mentioned above.