Equipment Engineer
uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
Purpose of the role
As Equipment Engineer you are responsible for the up-time of equipment during its complete life cycle. From registration to decommissioning of the equipment, validate, maintain and calibrate the equipment and you’re doing everything to keep the downtime of equipment as short as possible.
Place in the Organization
Engineering AMS is part of Operations AMS
Key result areas (major duties, accountabilities and responsibilities)
- Writing of URS/Risk Assessments/Change Controls/Criticality Assessments/Validation Protocols and Reports
- Coordinating validation activities by third parties and internal departments in accordance with the Project Validation Plan
- Coordinating and executing preventive and corrective maintenance of equipment, including GMP reporting of maintenance and calibration activities.
- First response on breakdowns of critical instruments.
- Keep in close contact with internal clients for aligning production and maintenance schedule to minimize the impact of maintenance.
- Regular meetings with lab managers, to discuss outstanding quality issues, upcoming maintenance, breakdowns and all other equipment related questions.
- Setting up adequate maintenance and calibration documentation systems and keeping these systems updated according GMP guidelines.
- Keeping a planning system in place and up to date for maintenance and calibration activities. Develop planning efficiencies by setting up maintenance periods.
- Coordinate in-depth, complex trouble shooting on equipment
- Being the intermediate for technical issues between uniQure and third party contractors.
- Create equipment maintenance and or calibration related SOP’s, Forms and or Work Instructions.
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Qualifications & Skills
- Minimal technical MBO 4 level or equivalent by training or experience
- independently solve problems at their own discretion
- Experience in the field of calibrations and/or validation is an advantage
- Experience of computerized systems and testing is an advantage
- Knowledge of measurement and control technology
- Knowledge of GMP.
- You are independent but also a team player
- You have a positive and flexible attitude.
- You are service-oriented and problem-solving, you are a doer and consider the needs and expectations of (internal) customers.
Core competencies
- Strong social communication skills in both Dutch and English, both spoken and written
- Service-oriented and problem-solving, consider the needs and expectations of (internal_ customers)
- Positive and flexible attitude.