Autoclave Performance Qualification Specialist

• Design, execute, and document performance qualification protocols for autoclave systems, including cycle development, validation, and re-qualification
• Perform risk assessments, data analysis, and statistical evaluations to verify autoclave efficacy (e.g., heat distribution, penetration, and lethality)
• Collaborate with cross-functional teams (Engineering, Validation, and Operations) to resolve equipment issues and implement improvements
• Maintain detailed records, generate reports, and ensure compliance with regulatory requirements (e.g., 21 CFR Part 11, Annex 1)
• Train staff on autoclave operations and participate in audits and inspections
• Stay updated on industry best practices and emerging technologies in sterilization validation

• Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred)
• 3+ years of experience in pharmaceutical or biotech validation, with a focus on autoclave or sterilization equipment
• Proficiency in validation software (e.g., Kaye Validator, Ellab), statistical tools (e.g., Minitab), and regulatory standards
• Strong analytical skills, attention to detail, and ability to work in a fast-paced, regulated environment
• Excellent communication and teamwork abilities

Certification in validation (e.g., ASQ CQE) or equivalent

• medical
• dental
• vision care
• comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• support for working families (backup dependent care, adoption assistance, infertility coverage, family building support)
• behavioral health solutions
• paid parental leave
• paid caregiver leave
• training programs
• professional development resources
• opportunities to participate in mentorship programs, employee resource groups, volunteer activities