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, CAPAs, and supporting internal, regulatory, and client audits and root cause analysis.
* Coaching, steering, and training in Engineering departments in the field of quality.
* Providing support in technical and quality expertise to steer decisions in preparation for, during, and after manufacturing activities.
* Handling and processing information reports and reviewing Maintenance, Calibration, Validation & Plant Engineering, and Facilities work.
* Leading progression of assigned projects, communicating risks timely, and seeking to resolve challenges, both internally and externally.
* Actively building and maintaining internal and external networks within the defined expertise area.
* Ensuring individual trainings are up-to-date and aligned to Thermo Fisher guidelines and systems.
* Representing 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.
* Ensuring that activities for Maintenance & Calibration, Facilities, and Validation & Plant Engineering are within regulatory requirements.
* Responsible for continuous improvements in costs and results within the scope of activities.
* Following EH&S guidelines and, when vital, contributing to EH&S improvement activities.
* Achieving strategic and assigned departmental goals within Engineering, which are in line with the corporate goals.
* Performing 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 equivalent (e.g., Biochemistry, Biology, Biotechnology, Chemical Engineering, Chemistry).
* Excellent command of 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.
* Experience in Biopharma and cGxP environment.
Competence
* Clear communicator.
* Data-driven problem solver.
* Self-initiated and autonomous in time management and project management.
* Comfortable working with external customers in straightforward projects.
* Experience in navigating and handling conflicts.
* High degree of self-awareness.
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