Job Information
ThermoFisher Scientific Engineer II, Manufacturing Engineering in Groningen, Netherlands
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The quality Engineer will support the Maintenance & Calibration, Facilities and Validation & Plant Engineering departments in Engineering, Groningen. The position will be responsible for the quality of the processes within the department.
Key areas of accountability/responsibility
Monitoring, drafting, coordinating and handling deviations, investigations, change requests, change assessments, CAPA' s and support internal, regulatory and client audits and root cause analysis
Coaching, steering and trianing in Engineering departments in the field of quality
Provide support in technical and quality expertise to steer decisions in preparation for, during and after manufacturing activities.
Handling and processing information reports and review of Maintenance, Calibration, Validation & Plant Engineering and Facilities work.
Lead progression of assigned projects, communicate risks timely and seek to resolve challenges, both internally and externally.
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.
Ensure that activities for Maintenance & Calibration, Facilities and Validation & Plant Engineering are within regulatory requirements
Responsible for continuous improvements in costs and results within scope of activities.
Follows EH&S guidelines and when vital, chip in to EH&S improvement activities.
Achieving sytrategic and assigned departmental goals within Engineering, whihc are in line with the coperate goals
Perform other duties as assigned.
Knowledge and education level
Minimal HBO Level, or Higher Vocational Education, BSc or equivalent level through education, training and experience in Engineering or equivilant (E.g. Biochemistry, Biology, Biotechnology, Chemical Engineering, Chemistry).
Excellen command in English
Required level of experience
Experience in quality Engineering or equivalent quality role
Experience in the following areas Maintenance & Calibration, Facilities and Validation & Plant Engineering
Experienced in Biopharma and cGxP environment
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.