Validation Lead

Role Summary

Summary: Bring your expertise to a role where your decisions directly safeguard product quality, patient safety, and regulatory trust. As our Validation Lead in Indianapolis, you will shape and own the site’s end to end validation strategy—process, cleaning, primary packaging, and ongoing process verification—so manufacturing stays inspection ready and continuously compliant with current Good Manufacturing Practice. You’ll partner closely with cross-functional teams to orchestrate the Validation Master Plan, monitor meaningful performance indicators, and proactively manage risk. If you thrive on building clear standards, coaching teams, and turning complex technical challenges into practical, reliable solutions, this role gives you the platform to make an impact that matters. Location: Indianapolis, IN. Relocation Support: Yes.

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 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.

Qualifications

• Required: Bachelor’s degree in Biomedical Engineering, Chemistry, Pharmacy, Chemical Engineering, or Pharmaceutical Technology.
• Required: Minimum 5 years’ experience in manufacturing, technical development, or quality within the pharmaceutical industry.
• Required: Hands-on experience leading and managing validation projects.
• Required: Strong knowledge of manufacturing processes, process equipment, and applied statistics.
• Required: Proven ability to write and review technical reports and validation documentation.
• Required: Fluent in English and proficient in the local site language.

Education

• Bachelor’s degree in Biomedical Engineering, Chemistry, Pharmacy, Chemical Engineering, or Pharmaceutical Technology