Manufacturing Science & Technology (MSAT) Process Engineer II DSP

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Office Job

About the Role

Join our team as a Manufacturing Science & Technology (MSAT) Process Engineer II DSP, where you'll contribute to ensuring consistent production of therapeutic products. As part of our Manufacturing Sciences team, you'll work at the intersection of research and production, supporting process optimization, technology transfer, and continuous improvement initiatives. You'll collaborate with cross-functional teams to resolve technical challenges and ensure robust, scalable manufacturing processes that meet quality standards.

Key Areas of Accountability and Responsibility

• Deliver MSAT work (both client programs and internal projects) by leading straightforward projects, or supporting sophisticated ones in a timely, right-first-time and customer-centric manner
• Represent Thermo Fisher as (support) technical project lead, in customer communications and internal discussions
• Provide support in technical and technological expertise to steer decisions in preparation for, during and after manufacturing activities
• Support process validation studies by coordinating (and completing) studies, ensure running activities are on track and support lead PE in accurate completion of approved validation reports
• Lead progression of assigned projects, communicate risks timely and seek to resolve challenges, both internally and externally
• Support and implement new production processes; and optimize existing ones, with the objective to improve cost, speed, and quality
• May act as site project lead in the implementation phase
• Actively 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 internal and external audits on technology transfer across clinical and commercial phases, implementation of manufacturing processes, Process Validation, and sophisticated manufacturing remediation
• May coach MSAT and multi-functional colleagues for onboarding or cross-training purposes
• May act as domain expert in GMP-compliant trainings
• Works with functional managers to ensure knowledge and skills are gathered in a balanced manner
• Is scheduled for MSAT after-hours on-call when needed and, may be on-site after-hours for remediation in critical cases
• Follows EH&S guidelines and when vital, chip in to EH&S improvement activities
• Perform other duties as assigned

Knowledge and Education Level

• Recognized university degree in one of the scientific fields relevant to the production of biopharmaceuticals (e.g., Biochemistry, Biology, Biotechnology, Chemical Engineering, Chemistry)
• Has completed facility fit assessments, material qualification, process models, scaling from bench scale to large scale, process descriptions, process flow diagrams, equipment automation recipes, process remediation, deviation investigations and implementation of corrective/preventive actions
• Has (partially) 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 3 years of technology transfer experience in downstream bioprocessing; Or
• More than 5 years of hands-on experience in process development or manufacturing downstream bioprocessing

Competencies

• Clear communicator
• Data-driven problem solver
• Has self-initiative and is autonomous in time management and project management
• Comfortable to work with external customers in straightforward projects
• Has experience in navigating and handling conflicts
• High degree of self-awareness

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity Statement

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.