Validation Lead
About the Role
Key Responsibilities:
- Develop and implement site validation strategies for process, cleaning, packaging, and ongoing process verification.
- Oversee the Validation Master Plan, ensuring timely execution and audit readiness.
- Provide technical expertise and guidance for risk assessments and validation documentation.
- Lead validation activities, ensuring compliance with Novartis and regulatory requirements.
- Partner with cross-functional teams to support equipment, utilities, and analytical method qualification.
- Facilitate product transfers and launches by aligning validation approaches and generating registration data.
- Monitor validation performance indicators and proactively address challenges to maintain continuous compliance.
The salary for this position is expected to range between $114,100 and $211,900 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Essential Requirements:
- Bachelor’s degree in Biomedical Engineering, Chemistry, Pharmacy, Chemical Engineering, or Pharmaceutical Technology.
- Minimum 5 years’ experience in manufacturing, technical development, or quality within the pharmaceutical industry.
- Hands-on experience leading and managing validation projects.
- Strong knowledge of manufacturing processes, process equipment, and applied statistics.
- Proven ability to write and review technical reports and validation documentation.
- Fluent in English and proficient in the local site language.
Role Requirements
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: Learn about all the ways we’ll help you thrive personally and professionally.
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