Equipment And Maintenance Engineer

Il y a 3 jours

Namur, Wallonia, Belgique LinkedIn Temps plein

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Introduction:

Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.

Based in Gembloux, Intressa Vascular is a clinical-stage company developing an innovative medical implant to address life-threatening cardiovascular conditions such as aortic dissection.

Our mission is to help physicians address the devastating effect of aortic dissection by delivering next-generation endovascular treatment.

To strengthen our team, we are looking for an Equipment and Maintenance Engineer.

Job purpose:

Reporting to the Operations Director, the Equipment & Maintenance Engineer is responsible for performing equipment qualification and maintenance activities to ensure production and test equipment remain qualified, reliable and fit for their intended use throughout their lifecycle. The role is hands-on, performing equipment qualification, preventive and corrective maintenance, and maintaining the associated quality documentation in close collaboration with the Facility Manager.

Duties and Responsibilities:

He/She is responsible, in a proactive and objective-driven manner, for:

1) Equipment Qualification

Plan and perform IQ/OQ activities in accordance with the qualification and maintenance plan.
Verify the effectiveness of qualification activities and support equipment requalification where required.
Participate in commissioning and qualification of new or modified equipment.

2) Equipment Maintenance and Lifecycle

Plan and perform preventive and corrective maintenance activities together with the Facility Manager.
Verify the effectiveness of maintenance activities to ensure equipment remains in a qualified state.
Monitor equipment performance and report recurring technical issues.

3) Documentation and Quality Support

Maintain qualification, maintenance and equipment history records in accordance with the Quality Management System.
Support equipment and facility change control activities.
Contribute to non-conformity investigations, root cause analysis (RCA), CAPA and internal/external audits related to equipment.

Profile:

Bachelor's degree in industrial engineering (mechanical, electromechanical or related discipline) with at least 2 years of professional experience, or 4 years of professional experience in industrial maintenance within the medical device or pharmaceutical sector.
Hands-on experience in equipment qualification (IQ/OQ) and/or preventive and corrective maintenance in a regulated manufacturing environment.
Knowledge of ISO 13485 and/or GMP principles applicable to regulated manufacturing environments.
Experience supporting equipment installation, commissioning or qualification is considered an asset.
Autonomous, hands-on mindset with a proactive and problem-solving attitude.
Excellent communication skills (written and verbal), with strong analytical abilities.
High level of attention to detail, excellent organizational skills and time management.
Good command of spoken and written English.

Our offer:

A challenging and diversified position within a high-potential innovative medical device company.
A human-sized, collaborative, and respectful work environment. xlxgzvr
An attractive compensation package in line with the position responsibilities and your experience.

Equipment And Maintenance Engineer

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