Validation Expert

Salary Range:

€52,200.00 - €96,900.00

 

Band

Level 3

 

Job Description Summary

#LiHybrid
Location: Puurs

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.

 

Job Description

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 reviewed
periodically.

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. 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.

 

Skills Desired

Assembly Language (ASM), Change Controls, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge   (Inactive), Including Gdp (Inactive), Knowledge Of Capa (Inactive), Knowledge Of Gmp (Inactive), Lean Manufacturing, Manufacturing Processes, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation (Inactive), Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Six Sigma, Standard Operating Procedure (SOP), Workforce Planning