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/A
In 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