Apr 12, 2022

Job Description

Be at the front line for innovative biotechnological products that reach patients in more than 150 countries! As part of the Manufacturing Science & Technology team you can make a difference to millions of patients around the world by continuous improvement of commercial drugs and upcoming exciting launch products.

Responsible for developing validation strategy and coordinating validation activities required to complete assigned validation projects in support of the operation of the Morris Plains according to the corporate policies, SOPs, cGMPs, and FDA regulations. Provide technical support and services to the Process Unit Departments. Design, plan, and perform complex and diverse tasks that directly support new Cell and Gene Therapies projects during development, clinical and commercial phases. Basic understanding of data and statistical analysis of experimental results. This position requires a scientific attitude with strong technical and/or engineering knowledge, as well as strong ability to work in a matrix organization with interfaces to Mfg, AS&T/QC, TR&D, QA.

- Establish, write and maintain Validation Master Plan for manufacturing process, aseptic process, and shipping validation Support Validation Lead in ensuring that responsible departments implement and maintain the VMP activities including, annual revalidation process simulation procedures. Implement the strategy for continued process verification (CPV) that ensures all critical process parameters and quality attributes are monitored or analyzed, and actions taken in case of trends or deviations.

- Reviews risk assessments for CPV. Build local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments.

- Prepares/update validation protocols; execute test plans, collect samples, analyzing test results, and prepares validation reports

- Peer review/approves validation plans, validation protocols, analyses and approves test results, and approves validation reports generated by junior team members and contract personnel

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

- A minimum of BS in Biochemistry, Chemical or Biochemical Engineering, Microbiology, Biotechnology, or other Life Science-related field. Advanced degree in any of the above fields is preferred.

- Minimum 7 years of experience in Biopharm late stage development, validation, manufacturing or a technical support function.

- Proven process understanding (Pharma, GMP, Regulatory aspects).

- Skilled in aseptic processing and the use of single use technology

- Familiarity with statistical tools and methods strongly preferred.

- Familiarity with cGMP regulations and practices is a must; first-hand experience in cGMP operations is preferred.

- Familiarity with modern project management methodology and tools.

- Ability to plan, prioritize and implement multiple tasks simultaneously under tight deadlines.

- Strong verbal and written technical and interpersonal skills.

Why consider Novartis?

769 million! That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] (mailto:[email protected]) call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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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 (https://talentnetwork.novartis.com/network)

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Novartis Technical Operations
Morris Plains, NJ
Technical Operations
Full Time
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Principal Validation Specialist

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