Your Impact

As an experienced Computerized System Validation (CSV) Engineer, you play a key role in the implementation and management of software systems used in the Life Sciences sector. More specifically, your mission is to ensure the quality and regulatory compliance of software systems used across all GxP areas. Systems in scope include site-specific lab instruments (e.g. HPLC software), production equipment (e.g. capsule filling machine), but also globally used web applications, medical devices, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP, …

Your responsibilities include:

• You advise the customer regarding the applicable regulations for your project/system.
• You are responsible for defining and documenting a risk-based validation approach for your project/system.
• You plan and manage all validation activities required for your project/system.
• You (co-)write validation documentation (e.g. Validation Plan/Report, System Criticality Assessment, User Requirements, …) and testing documentation (Test Plan/Report, Test Scripts, …).
• You are in close contact with various system/project stakeholders and understand the interests and needs of business, IT and Quality Assurance.
• You (co-)write procedures (SOPs, Work Instructions) related to the use of your system.
• You are responsible for keeping your system in a validated state.
• You are able to provide system-specific validation support during audits and inspections.

Where you're going to get started

Ordina's Quality & Compliance (Q) team provides more than 100 expert consultants in 3 different practices, Laboratory, Production and Business Technology. Within these practices different roles are taken up by the Q&C engineers such as qualification and validation of equipment, production lines, cleaning, sterilization, utilities, software’s as well as business analysis, engineering, building, project management and so much more. Most of the Q'ers have a scientific background; often industrial engineers, bioengineers, biotechnologists, biomedical scientists, pharmacists, ... but historians, translators/interpreters, communication scientists, etc. also regularly find their way to our team.

This is you

• Graduate with a Master's degree in a scientific direction (Industrial Engineer, Bio Engineer, Chemistry, Biotechnology, Pharmacy,...) or equivalent by experience.
• Familiar with regulatory standards and guidelines (GAMP5, EU Annex 11, 21CFR Part 11, ISO9001...) and concepts such as QMS, Da-ta Integrity, CAPAs, GDPR,... .
• Knowledge of validation methodologies (Waterfall, Agile) within a GxP environment.
• Affinity with IT and basic knowledge of IT infrastructure qualification.
• Analytical and pragmatic thinking.
• Strong prioritization and planning skills.
• Strong sense of responsibility and accountability.
• Excellent communication skills in Dutch and English.

Benefits

• You will contribute to projects for top companies, both nationally and internationally.
• You will work in an exciting environment with a focus on knowledge and innovation.
• Your colleagues are pragmatic professionals, open to new ideas and initiatives.
• You keep your knowledge up to date by participating in trainings, workshops, competence centers and conferences.
• You are in the driver’s seat of your career.
• You enjoy benefits such as a company car, laptop, phone allowance, insurance, etc.

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