Experienced IT Validation Engineer
Veerle Heyvaert Resource Manager Q +32 478 77 48 57
Experienced IT Validation Engineer Contact Contact Veerle Heyvaert

Who are we looking for

Ordina’s Quality & Compliance team is highly educated, multidisciplinary, intensively trained, rich in practical experience and recognized by our customers as a valued partner in quality services. Our team members have a depth of knowledge of regulations, standards, guidelines and industry best practices (GxP, 21 CFR part 11, ICH, QMS, ISO,…).

The Ordina Q team consists out of Validation Engineers/Trainees, Validation Coordinators and Validation Managers offering advice, training, and support for all GxP activities and projects in areas ranging from process & product support to software & process validation, quality control and quality management systems. Following a science and risk-based approach, Ordina identifies the critical steps in processes, and helps to improve the effectiveness and efficiency of validation and documentation efforts.

As a Computer System Validation Engineer, you will support our customers in setting up and maintaining IT systems and solutions falling under regulatory requirements (GxP, 21 CFR Part 11,…). As a part of a project team on the customer side, with support of technical solution experts and developers, you prepare, execute, and finalize the validation of computer systems to be used in the production or development of pharmaceutical products. You are a competent partner for our customers in questions concerning computer system validation.

You are responsible for the execution of validation activities such as validation planning, preparing user specifications and verification documentation, SOP’s, …

You are able to complete training materials and provide training on topics that are in your area of expertise. 

What are the requirements?

  • Bachelor or Master level (pref. (bio)chemical engineering, bioscience engineering, bioinformatics, industrial Pharmacy or through experience…)
  • At least 3 years experience in CSV and a sound knowledge of following domains:  21 CFR Part 11, GxP, SOX, FDA, …
  • Excellent communication skills
  • Strong documentation skills
  • You are analytical, can set priorities and have the sense of planning and organization
  • Quality minded

What does Ordina have to offer?

  • Challenging projects within a versatile circle of customers
  • An open no-nonsense company culture with room for personal initiative
  • A high tech environment with focus on knowledge and innovation
  • A great number of workshops, trainings and events in cooperation with Ordina Academy
  • Real possibilities to grow within the company and to clearly define your career on the basis of an Human Talent Management Program
  • Regular team events and social company events
  • An attractive salary in accordance to the market situation with a wide remuneration package such as a company car, laptop…

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