Validation Expert
About this opportunity
#LiHybridLocation: PuursThe Validation Expert performs and manages the qualification status of validated process equipment and processes, as well as modification activities to comply with cGMP requirements, on time and in the intended quality, so that site validation program conforms to overall regulatory expectations.
Major accountabilities: Promote quality excellence: Take charge of preparing and verifying process requalification protocols and reports with meticulousness and attention to detail, ensuring that every step is accurately documented. Manage requalification activities: Plan and execute periodic requalification initiatives for manufacturing equipment and processes, including sterilisation, cleaning, and aseptic process simulations (medium fills). You will be the go-to person for ensuring smooth operations.Ensure regulatory compliance: Ensure that all requalification activities adhere to current regulatory requirements, proactively managing any deviations and providing recommendations to prevent recurrence. Your expertise will be crucial in maintaining our site's compliance.Maintain audit readiness: Maintain a state of audit/inspection readiness for all activities and projects, taking ownership of upholding our high standards of quality under your guidance.Share your expertise: Offer valuable technical expertise in conducting risk assessments and collaborate with cross-functional teams to effectively analyse and mitigate process risks. Your insights will not only ensure compliance but also optimise our operations for enhanced efficiency.Essential requirements:Scientific/Engineering Degree.Previous experience within Quality/MS&T/Production department of a GMP manufacturing site.Proactivity and flexibility.Fluent in English and Dutch.At Novartis, we’re committed to reimagining medicine together- and rewarding the people who make it happen.Expected Annual Base Salary Range: 52.200 - 96.900 EUR.The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewedperiodically.The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans,retirementplans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.Commitment to Diversity and Inclusion/EEO:Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 1527 comparable Manufacturing & CMC roles across 125 biopharma companies.
Salary context
456 of 1527 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1527 comparable roles
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Seniority mix
705 of 1527 peers have a known seniority level
Therapeutic area mix
7 of 1527 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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.
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.