Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join our team as a Manufacturing Science & Technology (MSAT) Process Engineer III - Downstream Processing, where you'll serve as a technical leader ensuring consistent production of therapeutic products. As part of our Manufacturing Sciences team, you'll work at the intersection of research and production, leading process optimization, technology transfer, and continuous improvement initiatives in downstream bioprocessing. You'll provide technical expertise to cross-functional teams, resolve complex manufacturing challenges, and ensure robust, scalable DSP manufacturing processes that meet quality standards. In this role, you'll represent Thermo Fisher as a technical expert to customers and may coach MSAT personnel on technical and technological aspects.

Key areas of accountability/responsibility

• Lead (or support as a coach) and deliver MSAT work (both client programs and internal projects) with the goal of being on-time, right-first-time and customer-centric
• Represent Thermo Fisher as technical project lead in customer communications and internal discussions
• Provide technical and technological expertise in downstream processing to steer decisions in preparation for, during and after manufacturing activities
• Lead process validation studies by preparing, coordinating (and executing) studies, ensure running activities are on track, and complete approved validation reports in a timely manner
• Monitor project progression, communicate risks timely and seek to resolve challenges, both internally and externally
• Lead site projects on state-of-the-art downstream processing technology and current compliance standards
• Co-develop and implement best practices, regulatory standards and new production processes; and optimize existing DSP processes, with the objective to improve cost, speed and quality. May act as site project lead in the implementation phase
• Participate and monitor technological developments in downstream bioprocessing and assess their applicability to Thermo Fisher
• Build and maintain internal and external networks within downstream processing expertise area
• Leverage individual and network experience to make sound judgements on issues outside domain expertise, including cost-benefit analyses
• Ensure individual trainings are up-to-date and aligned to Thermo Fisher guidelines and systems
• Represent Thermo Fisher at internal and external audits on technology transfer across clinical and commercial phases, implementation of manufacturing processes, Process Validation, and advanced manufacturing troubleshooting
• Coach MSAT and cross-functional colleagues for onboarding or cross-training purposes
• Act as subject matter expert in GMP-compliant trainings
• Work with functional managers to ensure knowledge and skills are captured in a sustainable and compliant manner
• Is scheduled for MSAT after-hours on-call when needed and, may be on-site after-hours for troubleshooting in critical cases
• Follow EH&S guidelines and when necessary, contribute to EH&S improvement activities
• Perform other duties as assigned

Knowledge and education level

• Recognized university degree in one of the scientific disciplines relevant to the production of biopharmaceuticals (E.g. Biochemistry, Biology, Biotechnology, Chemical Engineering, Chemistry)
• Has executed facility fit assessments, material qualification, process models, scaling from bench scale to large scale, process descriptions, process flow diagrams, equipment automation recipes, advanced process troubleshooting, deviation investigations and implementation of corrective/preventive actions
• Has executed 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 cell culture or downstream bioprocessing; Or
• More than 8 years of hands-on experience in process development or manufacturing of upstream or downstream bioprocessing; Or
• Skillsets and experience as deemed equivalent to above

Competence

• Clear communicator
• Data-driven problem solver
• Has self-initiative, is autonomous in time management and project management
• Comfortable to work with external customers in straightforward projects
• Has experience navigating and managing conflicts
• Is self-aware and is interested to accrue coaching skills

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.