Process optimization & validation lead

Department Info

Therapeutic Interventional Oncology (TIO) reflects Terumo's aspiration to be a Global leader in the field of Interventional Oncology. It’s combines the expertise of Quirem Medical in the radio-embolization field and other solutions, including chemoembolization and ablation.  

Job Summary

We invite you to join us as our Process Optimization & Validation Lead, becoming an active contributor to our growing Terumo Interventional Oncology (TIO) business. You will play a vital role in initiating, driving, and coordinating process development projects within our operations department. By fulfilling your crucial role, you will ensure that new or improved processes and products meet established criteria derived from operational, business, regulatory and user requirements.  

You will get the opportunity to drive the further development, as well as optimization and validation of our irradiation and nuclear laboratory processes. Your endeavours will contribute actively to an improved efficiency, safer working environment and cost savings. 

You will report directly to the Global Product & Irradiation Engineering Manager, Gerhard van Wolfswinkel.
 

Job Responsibilities

As our Process Optimization and Validation Lead (PO&V Lead), you will contribute actively to the development of the Terumo Interventional Oncology (TIO) operations. Your main responsibilities will entail:

• Acting as a SME for process verification and validation in process development projects
• Identifying opportunities for improvement in existing manufacturing processes, proposing and leading development solutions, working with key stakeholders to define projects the for development of new manufacturing processes or improvement of existing processes. In particular, identifying nuclear laboratory process bottlenecks, propose and implement solutions
• Applying proven techniques, like Six Sigma or similar, to develop and investigate technical solutions together with operations and external parties.
• Preparing QMS documents (e.g. process validation plans and reports) in relation to process verification and validation testing.
• Ensuring that products and processes comply with the requirements and fulfilling the business and customer needs
• Monitoring and reporting new processes and verifying effectiveness of improvements
• Performing and/or coordinating hand-on research and test activities including test at external locations such as nuclear reactors with radioactive material
• Performing validation activities with end-users of the processes (operators etc.) 
• Coherently explaining complex technical solutions to non-technical project team members and key stakeholders
• Dealing with changing priorities, managing uncertainty and dealing with complexity in a dynamic organization
   

Profile Description

You have obtained a relevant degree and can look back on 2 to 5 years of experience in process engineering, ideally in the field of medical devices or radiopharmaceuticals.

You are experienced in working within a multicultural and global environment

You can look back on previous experience in working with quality management systems in accordance with ISO standards (like 9001 and preferably ISO 13485 and CFR part 820)

Being knowledgeable of radioactivity and nuclear irradiation processes, as well as possessing a Radiation Hygiene Certification will be regarded as an asset (Level 5 or 3).

You possess excellent and communication skills. You are fluent in English. This involves both verbal and writing skills. 

You are detail-oriented, accurate, structured and possess excellent adaptive capabilities. In addition, you are a creative out-of-the-box thinker.

You ensure accountability and are driven to optimize work processes. Furthermore, you are a problem-solver and a team player. 

You are open to travel to our head office site in Deventer and occasionally to other sites depending on evolving business needs.

Offer

Working for Quirem as part of the Terumo Group means contributing to society through healthcare.  

We offer an attractive salary and benefits package, including a company car & fuel card or car allowance incentive scheme, an excellent health insurance package, and pension plan

We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.   

During your recruitment process, you’ll be able to have conversations with your future manager, Gerhard van Wolfswinkel, and other passionate associates.  

Interested to contribute to the growth of Terumo? Interested to find out more? Have a look at Terumo Europe's Corporate Video or visit our websites Quirem Medical & Terumo Europe

Contact Person

Jarne Jans - Talent Acquisition Officer & Recruitment Marketeer

• LinkedIn: www.linkedin.com/in/jarnejans 

Please upload your CV and/or motivation letter in English.