General information
Publication date
03/10/2025 Category
OPERATIONS - CONSULTING
Job title
CSV Engineer - Life Sciences - M/F/X
Contract
Permanent contract
Job description
About the role
This role involves ensuring compliance with cGMP standards through the validation of computerized be responsible for developing and executing validation studies generating documentation and maintaining the validated status of systems.
This position requires hands-on involvement and technical expertise in validation you have experience in the pharmaceutical sector and a strong understanding of quality and compliance regulations
Key responsibilities
- Develop implement and execute validation studies for cGMP-critical computerized systems regarding URS SIA DQ IQ OQ PQ RV and TM activities
- Generate validation documentation and assist with protocol execution for computerized systems
- Ensure validated status of systems complies with cGMP standards at all times
- Manage projects in accordance with Sanofi and cGMP regulatory standards
- Provide technical assistance on US FDA and EU validation requirements
Business Industry
Life sciences
Profile
About you
- Strong communication skills for effective collaboration and reporting
- Ability to work independently and adapt quickly to new challenges
- Competent knowledge of Computer Systems Validation processes
- Full understanding of relevant quality and compliance regulations
- Minimum of 3 years of experience in the pharmaceutical sector and GMP environment
Job location
Europe Belgium Flanders Antwerp
Location
Noordkustlaan 16B 1702 Dilbeek
Candidate criteria
Level of experience
1 to 3 years
General information Publication date 03/10/2025 CategoryOPERATIONS - CONSULTINGJob titleCSV Engineer - Life Sciences - M/F/XContractPermanent contractJob descriptionAbout the roleThis role involv...
General information
Publication date
03/10/2025 Category
OPERATIONS - CONSULTING
Job title
CSV Engineer - Life Sciences - M/F/X
Contract
Permanent contract
Job description
About the role
This role involves ensuring compliance with cGMP standards through the validation of computerized be responsible for developing and executing validation studies generating documentation and maintaining the validated status of systems.
This position requires hands-on involvement and technical expertise in validation you have experience in the pharmaceutical sector and a strong understanding of quality and compliance regulations
Key responsibilities
- Develop implement and execute validation studies for cGMP-critical computerized systems regarding URS SIA DQ IQ OQ PQ RV and TM activities
- Generate validation documentation and assist with protocol execution for computerized systems
- Ensure validated status of systems complies with cGMP standards at all times
- Manage projects in accordance with Sanofi and cGMP regulatory standards
- Provide technical assistance on US FDA and EU validation requirements
Business Industry
Life sciences
Profile
About you
- Strong communication skills for effective collaboration and reporting
- Ability to work independently and adapt quickly to new challenges
- Competent knowledge of Computer Systems Validation processes
- Full understanding of relevant quality and compliance regulations
- Minimum of 3 years of experience in the pharmaceutical sector and GMP environment
Job location
Europe Belgium Flanders Antwerp
Location
Noordkustlaan 16B 1702 Dilbeek
Candidate criteria
Level of experience
1 to 3 years
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