Qualification & Validation Engineer Life Sciences MFX
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Job Location:
Monthly Salary:
Posted on:
21-10-2025
Vacancies:
1 Vacancy
Job Summary
General information
Publication date
04/11/2025Category
OPERATIONS - CONSULTING
Job title
Qualification & Validation Engineer - Life Sciences - M/F/X
Contract
Permanent contract
Job description
About the role
This role involves the development implementation and execution of validation activities for small-scale equipment and related software.
The successful candidate will conduct validation studies for cGMP-critical process systems ensuring compliance with cGMP user and regulatory requirements.
This position requires hands-on involvement in qualification of systems interpreting industry standards and maintaining compliance with cGMP cGLP and specific procedures. You will also provide technical assistance on current US FDA and EU validation requirements ensuring projects align with all necessary regulatory standards
Key responsibilities
- Develop implement and execute URS SIA DQ IQ OQ PQ RV and TM activities for equipment
- Conduct validation studies to demonstrate compliance with cGMP and regulatory requirements
- Perform qualification of systems interpreting standards to specific cases
- Ensure systems maintain qualified status in compliance with cGMP at all times
- Provide technical assistance on US FDA and EU validation requirements
Business Industry
Life sciences
Profile
About you
- Strong knowledge of cGMP requirements in a regulated environment
- Understanding of relevant quality and compliance regulations
- Ability to troubleshoot validation issues effectively
- Proficiency in quality management systems
- Experience in qualification of small-scale equipment and related software
Job location
Europe Belgium Flanders
Location
Candidate criteria
Level of experience
1 to 3 years
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Leading digital engineering consultancy specializing in human-centered AI. Deep expertise in AI, data, cloud & edge computing worldwide.
