Process Engineer II, DSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Key areas of accountability/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/Co-develop and implement regulatory requirements and 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

Competence

• 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