For one of our clients in Geel, we are currently looking for a "Validation Engineer Computerized Systems".
We are looking for someone who has project experience with the rollout software packages and with sufficient validation experience of Computerized systems / digital tools (e.g. BioLIMS Laboratory Execution System, Electronic flows, ...).
You will be responsible for data migration activities and all related tests. Additionally you will have to rewrite the related procedures.Towards the end of the project, training of the new application will also be your responsibility.Experience with Agile methodology is a plus.
- Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
- Development, implementation and execution of validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
- Performing validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP, cGLP and company Procedures.
- Ensuring that the Validated Status of computerized systems comply with cGMP at all times.
- Ensuring projects (moderate scale & complexity) are managed in conjunction with all required company and cGMP regulatory standards.
- Staying up to date regarding 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.
- Generating validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems.
- Responsible for the validation documentation through approval and implementation.
- Providing input in review/assessment of changes as to whether they affect the validated status and validation-documentation.
- Conducting statistical analysis of validation (raw) data & testing results.
- Investigating/troubleshooting moderately complex validation problems.
- Developing moderately complex protocols to ensure quality standards.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Minimum 5 years of experience working in a pharmaceutical sector and GMP environment
- Good knowledge of English and Dutch
- Project management: researching, ensuring that everything is delivered on time
- Validation tests
- Data migration
- Writing and adjusting procedures
- Training experience
- 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
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16637