CSV Engineer

Job content

For a big company in the Biotech Industry, we are looking for a CSV Engineer. In this role, you will have various responsibilities:

• 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 company 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 company 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.
• Investigates/troubleshoots moderately complex validation problems.
• Develops moderately complex protocols to ensure quality standards

Benefits

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Have you got what it takes?

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

You can count on the following skills/experiences:

• 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,…
• Minimum 5 years experience working in a pharmaceutical sector and GMP environment
• Good knowledge ENG + NL (DUTCH IS A MUST)