CSV Engineer Consultant

Job description

Can’t wait to make an impact on the world? You’re not alone. Join us in driving progress in the working world and beyond. Your journey with us As a Computer System Validation (CSV) Engineer Consultant , you will support our clients in the Life Sciences & Health Care industry in ensuring their IT systems are compliant, robust and audit ready. You will: Plan and coordinate IT quality / computer system validation (CSV) projects and/or IT audits for GxP environments. Advice on regulatory compliance, IT quality and CSV in support of business and IT stakeholders. Define validation strategies and risk based approaches, aligned with regulations, standards and client processes. Create and maintain validation deliverables, such as validation plans, risk assessments, user requirements, test protocols (IQ/OQ/PQ), traceability matrices and validation reports. Plan and coordinate validation testing, working closely with business users and IT teams as independent quality advisor. Perform system audits and gap assessments to verify compliance with good practices (e.g. GxP, data integrity) and regulatory requirements. Support the design and implementation of Quality Management Systems (QMS), including processes, procedures and templates related to IT quality and CSV. You’ll work in multidisciplinary teams and have the opportunity to contribute to both project based assignments and long term managed services engagements. Let's talk about you You are passionate about quality, regulatory compliance and technology, and you feel at home in a structured, regulated environment. You have: 2 to 6 years of experience in IT quality, computer system validation (CSV) and/or IT audit. A good understanding of Quality Management Systems (QMS) and related processes. Understanding of regulations and industry standards Experience working in Life Sciences & Health Care (pharmaceutical, biotech, medical devices, hospitals, etc.). Fluency in English. Dutch and/or French are a plus. Strong organizational skills, with the ability to prioritize and coordinate multiple activities. Diplomacy, creativity and a client and result oriented mindset, combined with excellent social and communication skills that allow you to build trust with both business and IT stakeholders. If you recognize yourself in this description and you want to grow as a trusted advisor in CSV and IT quality, we’d love to meet you. Who is Deloitte? We provide industry-leading audit and assurance, tax and legal, consulting and related services. We are committed to driving innovation across offerings to help our clients address their challenges, while giving our professionals opportunities to learn and grow in this era of transformation. In Belgium, +5000 dedicated professionals active in +10 offices, take great pride in bringing multidisciplinary expertise to a wide variety of clients, from national and international companies, small, fast-growing and large organizations to public institutions and governmental authorities. Why Deloitte? Be the true you! We foster diversity and inclusion and encourage you to bring your authentic self to work. Explore, question and collaborate while building a career that inspires and energises you. Never stop growing! Diversity of thought makes us stronger. At Deloitte, we tailor a personalized learning experience, offering you the opportunity to grow at your own pace and achieve maximum impact. We practice what we preach! As a Purpose-led organisation, at the heart of everything we do is a set of timeless principles and unifying values . Life looks different for each of us, so we created a varied benefits package that you can tap into: My Benefits My Choice , a flexible rewards plan tailored to your lifestyle and priorities Sustainable transport options offered by Mobility@Deloitte Flexible work arrangements for all and initiatives supported by Parents & Caregivers @Deloitte Wellbeing tips and activities powered by Energise@Deloitte Topped off with other health benefits and insurance opportunities Empowering our employees with flexible work arrangements remains essential in today's reality: Hybrid workplace: combination of home office and on-site (+10 offices in Belgium or client's premises). Part-time employment: all our jobs are open to full-time or part-time work under a 90% or 80% regime. Join us to make an impact together! Apply now! #LI-JV5