Validation Lead

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 to ensure 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.

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.