Apr 08, 2022

Job Description

Senior Validation Lead (f/m/d), Drug Product Schaftenau, Austria

>150! That is the number of countries in which we reach our patients and are at the front line for biotechnological products. As part of the Manufacturing Science & Technology team you can make a difference to millions of patients around the world by supporting the introduction, life cycle management and continuous improvement of medical devices or combination products.

Your key responsibilities:

Your responsibilities include, but are not limited to:
• Leading the validation team and overall responsibility for establishment, prioritization, execution and tracking of the validation master plan
• Developing, implementing, and managing the site process validation
• Compounding and filling process validations of biotechnological drug products
• Assembly and Packaging Process validation of combination products and concept of cleaning validation
• Revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs
• Establish local procedures & templates for respective process validation documentation in compliance with global regulatory expectations
• Work in close collaboration with the product stewards to maintain the process control strategy and with departments like production, development, regulatory, quality unit, etc.
• Participation in health authority inspections

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• University degree in chemistry, biology, pharmacy, or related field with minimum of 5 years of experience in pharma industry
• Experience in process validation and drug product manufacturing with thorough understanding of manufacturing processes and related process equipment
• Experience in executing process validation, having led and managed validation projects
• Good communication skills
• People leadership skills and ability to act in a sophisticated and rapidly changing business environment
• Proficiency in English and German

Desirable requirements:
• Critical thinking, collaborative approach, and a positive mindset
• Great teammate with the ability to foster stakeholder engagement

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 63.388,92/year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
Technical Operations
Full Time
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Senior Validation Lead (m/f/d)

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