Engineer II, Manufacturing Engineering

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