JOB DESCRIPTION:
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.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:EPD Established Pharma
LOCATION:Netherlands > Weesp : WWA A-C-D
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
Top Skills
What We Do
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
