Validation Expert

Oct 13, 2021

Job Description

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

Executing and managing equipment, facility, utility, process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. Design, plan, perform, interpret and report scientific experiments under the lead of the
department head to contribute to overall MS&T strategies and objectives.

Your responsibilities include, but are not limited to:

Support site lead in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
-Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
-Support site validation planning by writing and maintaining master plans for projects and the
site including equipment, facility, utilities, processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
-Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are
identified for on-going monitoring as a contributor to quality risk management activities.
-Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready
-Comply with applicable GxP regulations, SOPs, HSE, ISEC & other Novartis Guidelines in the laboratory and,
-Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving.
-Contribute to and maintain lab instructions, SOPs, templates.
-Support, qualification and calibration of lab / pilot equipment with accompanying documentation.
-Contribute to the evaluation of new equipment.
-Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation.
-Prepare and review appropriate GxP documentation including change requests.
-Participate in Tech Transfer activities from laboratory to industrial scale, support validation activities.
-Identify improvement options of current processes, propose business cases.

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

What you’ll bring to the role:

BS in biology, chemistry, engineering, or related. MS preferred
•Thorough understanding of manufacturing processes and related process equipment.
•3-5 years experience in executing process validation, having led and managed
validation projects.
•Expert in reviewing and writing technical reports.
•Fundamental understanding of standard pharmaceutical analytical testing.
Operations Management and Execution Project Management
Process and Cleaning Validation
Manufacturing Process/Product Expertise
Quality Change Control
Data analytics
collaborating across boundaries
Why Advanced Accelerator Applications (AAA)?

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking 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!

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.

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:
Millburn, NJ
Technical Operations
Full Time
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Validation Expert

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