CSV Engineer

Join an exciting environment where your expertise can play a crucial role in ensuring compliance and quality in the pharmaceutical sector. We are looking for a dedicated professional to drive the validation processes for critical computerized systems, ensuring they meet stringent regulatory standards.

The ideal candidate is a skilled Validation Engineer with a solid background in project management and validation of software packages. If you are detail-oriented, technically adept, and thrive in a compliance-focused environment, this position may be a great fit for you.

• You develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities.
• You generate validation documentation including protocols and reports, ensuring compliance with cGMP and regulatory requirements.
• You manage validation documentation through approval and implementation processes.
• You perform validation of systems in alignment with industry standards and cGMP procedures.
• You ensure that the validated status of computerized systems remains compliant at all times.
• You manage projects according to all necessary regulatory standards.
• You keep informed about emerging validation regulations and provide technical guidance on US FDA and EU requirements.

• You have at least 3 years of experience in a similar role within the pharmaceutical sector and GMP environment.
• You possess competent knowledge of Computer Systems Validation.
• You have a full understanding of relevant quality and compliance regulations.
• You are capable of troubleshooting validation issues effectively.
• You are an excellent communicator.
• You are able to work independently and demonstrate quick learning abilities.
• You can execute projects according to established plans.
• You have good knowledge of English and Dutch.
• Experience with DCS systems, specifically Emerson DeltaV, is an advantage.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
• Werk waar en wanneer je het beste presteert voor een ideale werk-privébalans.
• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.