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VACATURE — IT

CSV Engineer

We are TEC, your strategic partner for engineering projects in the construction industry, automotive industry, pharma, (petro) chemical, IT and telecom. Our mission? Create added value for our customers. With us, passion, integrity, teamwork and creativity come first. Thanks to our extensive network and years of recruitment experience, we offer interesting jobs tailored to your expertise and expectations. Our team stands ready for an excellent follow-up! In this way we guarantee a fascinating and pleasant working environment for all our consultants.

We are an important partner for our customer in Geel, an international pharma group with head office in Paris, 104.000 employees worldwide, based in 50 subsidiaries.

Responsibilities

Key Accountabilities:

  • Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
  • Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and Sanofi Procedures.
  • Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times.
  • Ensures projects (moderate scale & complexity) are managed in conjunction with all required Sanofi and cGMP regulatory standards.
  • Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
  • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems.
  • Responsible for the validation documentation through approval and implementation.
  • Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
  • Conducts statistical analysis of validation (raw) data & testing results.
  • Investigates/troubleshoots moderately complex validation problems.
  • Develops moderately complex protocols to ensure quality standards.

We are looking for someone who has project experience with rolling out software packages and who also has validation experience.

Data migration activities must be performed and related tests must be carried out. Current procedures should also be adapted or rewritten. Towards the end of the project, training of the new application will also have to be done.

  • Project management: researching, ensuring that everything is delivered on time
  • Validation tests
  • Data migration
  • Writing and adjusting procedures
  • Training

Profile

Skills/experience:

  • Strong communication skills
  • Capable of working independently and learns fast 
  • Able to execute project to plan
  • Competent knowledge of Computer Systems Validation
  • Knowledge of validation publications
  • Full understanding of relevant quality and compliance regulations
  • Capable of troubleshooting validation issues associated with projects, process development,…
  • experience with working in a pharmaceutical sector and GMP environment
  • Good knowledge ENG + NL
  • Education: Master in Science  (e.g. biotechnology)  / Master electromechanics
  • Background: automations / IT / Validation

Aanbod

In addition to a contract with an attractive salary, we offer you:

  • an exciting employer in full expansion that offers many future opportunities for your further career in the technical sector;
  • a lot of extra-legal benefits that fit your contract type and your own preferences (such as a company car / bicycle, group insurance, daily allowance);
  • personal contact with and support of our close team of Office Manager, Sales Managers and HR Coördinators;
  • a personal gift on special occasions (birthday, anniversary, ...);
  • occasional treats at the yard or customer site;
  • and last but not least: the chance to build up a large network and to share your experiences and knowledge with other technical profiles.
SOLLICITEER NU