Sr. Computerized System Validation Specialist
About this opportunity
Senior CSV Specialist
At Abbott Olst, we work every day on life-saving nutritional and pharmaceutical products. Within Manufacturing Automation, we are looking for a CSV Specialist who ensures reliable and compliant computerized systems.
Location: Olst, The Netherlands. This is an onsite position that requires you to be onsite a minimum of 4 days a week.
About the Department
Manufacturing Automation consists of Application Managers, Automation Engineers and MES Designers and supports production, laboratories, facilities and utilities. The department forms the bridge between technology, compliance and the production departments.
The role
You are the SME for CSV, Data Integrity and GMP compliance;
You lead complex validation and implementation projects;
You develop CSV standards, governance and procedures;
You translate new regulations such as NIS2, Annex 11 and CSA into the organization;
You coach colleagues and advise management and project owners;
You actively contribute to the future CSV strategy for the Olst and Weesp sites (OneNL).
Your Responsibilities
Prepare, review and effectively coordinate validation documentation
Handle deviations, exceptions and CAPAs
Support audits and inspections
Ensure continuous availability of up-to-date information, reports and evaluations regarding Computer System Validation
Collaborate with QA, Operations, Engineering and IT
Ensure compliant lifecycle management of computerized systems
Act as the CSV project SME for projects involving automation aspects.
What Do You Bring?
Bachelor's or Master's level education, preferably in Process Engineering, Automation or Business IT
A minimum of 3-5 years of CSV experience in a GMP environment
Demonstrated experience as an SME or lead in validation projects
Knowledge of GAMP5, NIS2, GMP Annex 11, Data Integrity and CSA
Strong stakeholder management and advisory skills
Fluency of both Dutch and English, spoken and written
Why Abbott?
You will have a visible role within a modern pharmaceutical environment where digitalization, compliance and continuous improvement are central. You will work with experts from various disciplines and have ample opportunities for development and impact.
Application
Apply directly with your CV! For questions, please email us at recruitment.netherlands@abbott.com and a member of our Talent Acquisition Team will get back to you shortly.
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 230 comparable Senior Quality roles across 59 biopharma companies.
Salary context
58 of 230 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 230 comparable roles
+ 23 more countries
Seniority mix
230 of 230 peers have a known seniority level
Therapeutic area mix
0 of 230 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.