Validation Expert

Job ID

REQ-10082656

Jul 31, 2026

Belgium

Available in: English

Summary

#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.

About the Role

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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

Primary location salary range

€52,200.00 - €96,900.00

Division

Operations

Business Unit

Production / Manufacturing

Location

Belgium

Site

Puurs

Company / Legal Entity

BE13 (FCRS = BE013) Novartis Manufacturing NV

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

Technical Operations Operations Belgium

Job ID

REQ-10082656

Validation Expert

Apply to Job

Job ID

REQ-10082656

Validation Expert

Apply to Job