CSV Validation Engineer
Life Sciences
Validation and Qualification
Master
Medior (3+)
- Location
- Geel, Antwerp
- Work type
- Consultancy
- Work model
- Fulltime, On-site
Our client, a leading pharmaceutical company, is seeking a CSV Validation Engineer to join their team. This role focuses on the validation of software packages and computerized systems to ensure compliance with global regulatory standards.
Responsibilities
- Develop and execute validation documentation including URS, SIA, DQ, IQ, OQ, PQ, RV, and TM.
- Generate and maintain validation protocols and reports for cGMP-critical computerized systems.
- Manage the full lifecycle of validation documentation from initial approval through final implementation.
- Ensure the continuous validated status of systems in accordance with cGMP and cGLP standards.
- Provide technical assistance and guidance regarding current FDA and EU validation requirements.
- Assess the impact of system changes and troubleshoot complex validation issues to maintain compliance.
Requirements
- You have 3+ years of relevant experience within a pharmaceutical and GMP environment.
- You bring competent knowledge of Computer Systems Validation (CSV) and relevant quality and compliance regulations.
- You possess hands-on experience in executing validation studies and protocol generation for computerized systems.
- You're a fast learner with strong communication skills and the ability to manage projects independently.
- You have a good knowledge of English and Dutch.
Nice to Haves
- Experience working with DCS systems such as Emerson DeltaV.
- Ability to effectively troubleshoot complex validation issues.
Offer
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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