Validation Expert

Novartis Belux; Puurs-Sint-Amands; Sur place; EUR 52 000 - 97 000; Plein temps

Avantages offerts par ce poste

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Résumé du poste

Novartis is seeking a Validation Expert to manage the qualification status of validated process equipment and processes, ensuring cGMP compliance and timely delivery within the site validation program. You will lead requalification activities, prepare protocols and reports, ensure audit readiness, and collaborate across teams to assess and mitigate process risks.

The role requires meticulous documentation and proactive problem solving, with fluency in English and Dutch.

Qualifications

• Must have a scientific or engineering degree.
• Experience in Quality/MS&T/Production at a GMP manufacturing site.
• Proactive and flexible approach to work.
• Fluency in English and Dutch is required.

Responsabilités

• Promote quality excellence by preparing and verifying requalification protocols and reports with meticulous documentation.
• Plan and execute periodic requalification activities for equipment and processes (sterilisation, cleaning, aseptic simulations).
• Ensure regulatory compliance and manage deviations to prevent recurrence.
• Maintain audit readiness and uphold high quality standards.
• Share expertise in risk assessments and collaborate with cross-functional teams to mitigate process risks.

Connaissances

Quality mindset

GMP knowledge

Fluent in English and Dutch

Proactivity and flexibility

Formation

Scientific/Engineering Degree

Description du poste

Location: Puurs

Summary

The 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.

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 reviewed periodically.

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-culture

Benefits and Rewards:

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, retirement plans, wellbeing resources and global recognition programs.

• Insurance plans
• Retirement plans
• Wellbeing resources
• Global recognition programs
• Flexible and hybrid working options
• Minimum 14 weeks paid parental leave

Read our handbook (PDF 30 MB)