Autoclave Performance Qualification Specialist

About the role

We are looking for an Autoclave Performance Qualification Specialist to ensure the reliable operation of autoclave systems used in sterilization within our pharmaceutical manufacturing site. The role involves designing, executing, and documenting qualification protocols while maintaining compliance with GMP, FDA, and ISO standards.

Key responsibilities

• Develop, execute, and document performance qualification (PQ) protocols for autoclave cycles, including initial qualification, re‑qualification, and cycle development.
• Perform risk assessments, data analysis, and statistical evaluations to confirm heat distribution, penetration, and lethality.
• Collaborate with Engineering, Validation, and Operations teams to troubleshoot equipment issues and implement improvements.
• Maintain detailed records, generate validation reports, and ensure adherence to regulatory requirements such as 21 CFR Part 11 and Annex 1.
• Train staff on autoclave operation, support internal and external audits, and stay current with industry best practices.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
• Minimum 3 years of experience in pharmaceutical or biotech validation with a focus on autoclave or sterilization equipment.
• Certification in validation (e.g., ASQ CQE) is a plus.
• Strong analytical mindset and ability to work in a fast‑paced, regulated environment.

Required skills

• Validation software such as Kaye Validator or Ellab.
• Statistical analysis tools, e.g., Minitab.
• Knowledge of GMP, FDA, ISO standards, 21 CFR Part 11, and Annex 1.
• Risk assessment and data analysis techniques.

What we offer

• Competitive compensation and comprehensive benefits covering medical, dental, vision, and wellness programs.
• Support for working families, including backup dependent care and adoption assistance.
• Opportunities for professional development within a global, innovative organization.