Software Validation Engineer

Biocartis Mechelen

Full time |  Permanent  |  5 year  |  Salary type not mentioned Salary not mentioned  |  1 Jobs  | English,French

Job Description

Purpose of the position:
Validating and maintaining the validated state of IT Applications and IT Infrastructure.

Tasks/outcome domains

Ownership of the IT Applications SOP & IT Application Validation Master PlanPlanning and follow-up the  validation of IT Applications
GxP criticality & 21CFR Part11 assessment of IT applications
Gathering of user requirements & process descriptions from process owners
Support application owners in writing specification documentation
Writing of qualification protocols & review of qualification reports
Guiding process owners in creation of Work Instructions for IT Applications intended use
Support training of Work Instructions for IT Applications intended use
Ownership of the IT Infrastructure SOP & IT Infrastructure Validation Master Plan
Planning and follow-up the  validation of IT Infrastructure
GxP criticality assessment of IT infrastructure
Identification of infrastructure needs together with application owners and infrastructure owners
Writing of qualification protocols & review of qualification reports
Guiding infrastructure owners in creation of Work Instructions for installation, backup, restore & disaster recovery
Master or Bachelor in a relevant technical area, e.g. software engineering, chemical engineering, bio-chemistry or you have achieved a similar level by experience
Preferably 5 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry
Familiar with following regulations21 CFR 820 Quality System Regulation
21 CFR 11 Electronic records & signatures
Familiar with following harmonized standardsISO 13485 QMS Medical Devices
ISO 14971 Risk Management Medical Devices
Familiar with following guidanceGAMP 5
GAMP IT Infrastructure and control
AAMI TIR36:2007 Validation of software for regulated processes
Familiar with Agile Software development
Familiar with Change Control and Configuration Management
Good knowledge of Dutch and English
MS Office
Project specific Applications; e.g. ERP, LIMS, …
Result oriented and driven
Team player and eager to learn
Flexible and pro-active mindset
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
Please apply by e-mail (Resume only in English) to using the job ID 2016039 as a reference.

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