CSV Specialist
Abbott
**CSV Specialist**
Are you passionate about Computer System Validation (CSV) and ensuring data integrity in a regulated environment? Do you thrive on influencing strategy, coaching teams, and driving compliance excellence? If so, we want you on our team!
**Abbott Established Pharmaceuticals**
We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
**About the role**
As a **CSV Specialist** , you will play a critical role in safeguarding GMP-related computer systems. You’ll act as a trusted advisor and subject matter expert, guiding policy decisions, leading validation projects within the quality control department, and supporting audits with confidence.
**What You’ll Do**
+ Advise & Influence: Shape policy proposals and implementation strategies for CSV and data integrity in GMP environments.
+ Validate & Maintain: Ensure the validated state if laboratory software by managing change control and updating documentation in compliance with GxP and cybersecurity requirements.
+ Drive Compliance: Prepare and execute validation plans, protocols, and reports for computer systems.
+ Lead Audits: Represent CSV expertise during audits and project reviews.
+ Continuous Improvement: Conduct periodic system reviews and recommend re-validation when needed.
**What We’re Looking For**
+ Bachelor’s degree in STEM.
+ 2-3 years of relevant experience in Computer System Validation.
+ 2-3 years of experience in a laboratory environment is strongly preferred.
+ Strong knowledge of GAMP5 and regulatory guidelines (EU GMP Volume 4, Annex 210, 211, 11).
+ Analytical mindset with strategic influence and stakeholder management skills.
+ A proactive team player who drives results and anticipates challenges.
+ Fluent in Dutch and English, verbally and written.
**Why Join Us?**
+ Be part of a mission-driven organization committed to quality and compliance.
+ Work in a collaborative environment where your expertise makes an impact.
+ Opportunities for professional growth and continuous learning.
**Ready to make a difference?**
Apply now and help us shape the future of compliance! All applications needs to include a CV and cover letter.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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