(junior) CSV Engineer
Belgium, Vlaanderen, Mechelen
045710 Requisition #
9 hours ago Post Date
SGS is the world's leading inspection, verification, testing and certification company.
The company employs over 90 000 people and operates a network of more than 1 000 offices and laboratories around the world. In Belgium 1.650 people are working for SGS.
SGS Life Science Services carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities. SGS Life Science Services has also expertise in the quality control of pharmaceuticals.
We are currently looking for: (junior) CSV Engineer
The main task of the CSV Engineer is to manage and/or perform the implementation, validation and follow-up of all computer system projects within a GxP environment to ensure compliance with the current applicable regulations & guidelines.
This task will be performed in close collaboration with the Information Technology (IT) department, the Business Project Manager(s), with approval of the Operational Quality Assurance (OQA) and under the supervision of the Lead CSV Engineer and the CSV & BPS Manager.
* Make sure that the system is validated in accordance to the procedural documents.
* Outline validation approach
* Ensure validation according to approved approach
* Summarize validation activities
* Perform Periodic Reviews to ensure the system stays in a validated state.
* Manage changes requested to validated systems
* Manage system retirement
* Propose changes to procedures on an ongoing basis to improve the quality system of the CSV & BPS department.
* Preparation of and assistance during internal and client audits and/or inspections on Computerized Systems and validation related topics
You have a university degree in (life) sciences with a good affinity for Information Technology
Or you have a university degree in Information Technology with affinity for (life) sciences
or equivalent experience.
Having a good knowledge on computer system validation, GAMP, 21 CFR Part 11, EU Annex 11 and other related regulations is an asset.Proven experience as an independent validation project leader in the pharmaceutical industry, preferably GCP, is a big plus.
You are fluent in English, knowledge of Dutch is an asset.
Skills and personality:
· Good knowledge and big interest in IT
· Team Leader
· Inquisitive mind especially for computerized systems
· Good planner
· Team player
· Quality minded
· Good communication skills
· Reporting skills
· Good documentation practice
What we offer?
An interesting salary package including meal vouchers, insurances and a company car.
A good work-life balance and a fun working environment.
A professional environment where learning is always possible and open feedback is very much appreciated.
Are you interested or do you know somebody who might be?
Please submit your application via Femke.email@example.com