Engineer II, Manufacturing Engineering

Work ScheduleStandard (Mon-Fri)

Environmental ConditionsOffice

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

R-01312024