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Team Lead Verification Engineering

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Date: Jun 10, 2021

Location: Delft, NL

Company: Getinge

Applikon Biotechnology B.V., part of Getinge since January 2020, is a Dutch high-tech company and a world leader in the development and supply of advanced bioreactor systems from the laboratory to the pilot and production scales. Our mission is to provide reliable solutions that make it possible to save lives. We support the pharmaceutical industry (vaccines, regenerative drugs, antibodies, body tissues, biopharmaceutics and biosimilars) as well as industrial microbiology (enzymes, food & beverage, nutraceuticals, biofuels, biochemicals and bioplastics) in their upstream processes. Our main office is located in Delft (Netherlands) with two subsidiaries in the USA and UK. We have more than 180 employees working worldwide on development, production, quality control, marketing & sales, and after-sales support - all of which contributes to improvements in Life Science. That is our passion!

 

 

For our Product development department, we’re in search of a:

 

 

Team Lead Verification Engineering

 

Job description

The function of Team lead Verification Engineer (VE) is subcategorized in the group verification engineering of the department product development. As a team lead you till take charge of this department! Your main tasks will consist of maintaining the quality and compliance, development and maintenance of internal norms and instructions according to GAMP-guidelines. Assurer of order and control within lab affiliated areas, the availability of the lab equipment and if need be the management of staff regarding this equipment, the maintenance of the education plans and the qualifications of your department staff (VE). Furthermore, you will take care of the correct and time full registration of the working hours of the team and report the required data to the Director of Product Development.

 

 

Tasks and responsibilities

Leading the employees of the Verification Engineering department:

  •           The supporting, guiding, and monitoring of verification engineers to ensure quality/development standards are always being maintained.
  • Point of contact within the organization regarding verification and or validation subjects.
  • Supporting the director of product development regarding product development subjects and subsidized projects
  • Working on ‘issue tracking system’ and from there being able to generate verification reports and process reports.
  • You are the voice of the customer within the department and ensure their wishes are pursued.
  • The introduction of new technologies (for example automation processes).

 

Contribution as senior/specialist to the verification and validation tasks:

  • The advisement over and co-creation of specification- and test documents of new products and change proposals for existing products.
  • Writing validation plans based on risk analysis and statistical substantiation. 
  • Creating/maintaining the planning and the information of management regarding the process of the planning.
  • Fixing technical problems/complaints of customers
  • Supplying change proposals to the product teams.
  • Visiting customers on site to deal with their problems.

 

Profile

You have a completed degree in the form of a MSc/BSc bio(process)technology (or a relatable field) and experience in the field of bioprocess technology. You have affinity with the mechanical, electrical and software relatable aspects of product development. Knowledge of cGMP-, GAMP, FDA-guidelines and agile methodologies is a pre. You possess good leadership and organizational qualities and have good social skills. You are accurate and diligent in your working methods and have a good knowledge of the English language(reading/writing). Furthermore, you are in the possession of a driving license and are willing to make journeys abroad to work on location.

 

Offer

If you are interested in working in a dynamic organization with short communication lines and an informal culture, and where innovation and professionalism are highly valued, then please send your application to HR.Applikon@getinge.com