Lab Engineer Equipment

Department Info

The Terumo EMEA Quality and Regulatory department, operating from Haasrode (BE), provides supporting services related to quality, regulatory and complaints & vigilance to internal and external customers in EMEA.

The Laboratory Engineering Section (LES) team, as part of the Quality Assurance Development organisation, establishes the framework to ensure that all quality control (QC) tests are performed in compliance with the applicable standards, regulations and customer expectations, using state-of-the-art methods and equipment.

Job Summary

As Lab Engineer Equipment, you are the subject matter expert for all aspects related to the test equipment used in the labs, to ensure the quality of products and processes.

Job Responsibilities

By fulfilling your role, you are responsible for selection, purchase, implementation and management of lab equipment, in close collaboration with the relevant stakeholders. You are responsible for the initial qualification of lab equipment, as well as its life cycle management (maintenance of validation master plans, periodical review and evaluation of changes). Related to the above, you will also take up the responsibility for the validation of the software in these lab equipments, if applicable.

Furthermore, you take ownership to ensure that Terumo’s QMS procedures on Data Integrity are adhered to by all departments, by foreseeing the necessary training and support. You ensure that Data Integrity requirements are taken into account during implementation of new equipment and/or software, and you establish and perform audit trail reviews, where applicable.

To enable this, you keep yourself up to date with applicable standards and regulations to ensure the use of state-of-the-art equipment and processes.

You interact with other departments and teams to perform investigations and to implement countermeasures for deviations and failures, to participate in improvement projects and to provide advice during development projects.

As Subject Matter Expert for Lab Equipment Qualification and Software validation, as well as for Data Integrity, you are the first point of contact for internal (e.g. Production, Engineering, Regulatory Affairs, QC) and external customers. Therefore, you will be required to act as a spokesperson during customer audits and regulatory inspections.

In close collaboration with the Lab Engineer Calibration, you will assist in the execution of calibration activities of measurement instruments in our labs and production plants.

Profile Description

You are an enthusiastic teamplayer and look forward to complementing our team of experts.

You have obtained a Bachelor’s or Master’s degree in an Engineering, Scientific, Medical or Pharmaceutical oriented education. An equivalent that is provided through experience, will also qualify.

You can look back on a previous relevant working experience of at least 5 years.

You possess detailed knowledge concerning data integrity, validation and state-of-the-art laboratory equipment. Additionally, a substantial amount of knowledge related to ISO standards, as well as applicable European and FDA regulations and guidelines, will be regarded as an asset.

You are IT literate and proficient in statistics.

You are a self-driver, organized and accurate. In addition, you possess good people skills and are able to communicate efficiently on different levels.

You are fluent in English. This entails both verbal and written skills. Being fluent in Dutch is a plus.

Offer

Contact Person

Peter Coolen

Talent Acquisition Partner