Validation Engineer - AZ

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results.

By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit  and  . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit

We are seeking a detail-oriented and compliance-focused Pharmaceutical Validation Engineer to support validation activities across sterile and non-sterile compounding operations in our 503A and 503B pharmacy facilities. The ideal candidate will be responsible for ensuring that all systems, equipment, processes, and environments perform reliably and consistently according to regulatory and operational standards.

This role requires hands-on experience with commissioning and qualification (CQV), process and cleaning validation, and equipment/system lifecycle documentation in accordance with cGMP, USP , , , and FDA 21 CFR Part 210/211 standards. The candidate will collaborate cross-functionally with pharmacy operations, quality, engineering, and IT teams to maintain regulatory compliance and validation readiness.

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for clean rooms, HVAC systems, compounding equipment, and critical support systems.
• Create validation master plans, risk assessments (e.g., FMEA), traceability matrices, and standard protocol documentation.

• Perform validation testing including equipment calibration, challenge studies, and environmental monitoring qualification.
• Analyze validation data to verify compliance and identify trends or deviations; recommend corrective actions and process improvements.

• Prepare and maintain detailed validation reports, change control documentation, and CAPA records in compliance with cGMP and internal SOPs.
• Support audits and inspections by maintaining audit-ready documentation and presenting technical validation data.

• Execute CQV for pharmaceutical equipment, utilities (e.g., purified water, steam, compressed air), and facility systems to ensure readiness for commercial use.
• Review vendor documentation and FAT/SAT results to support qualification efforts by coordinating with various vendors on a day to day basis and attending vendor FATs.

• Conduct process validation for sterile and non-sterile compounding workflows, ensuring consistent performance within defined parameters.
• Perform cleaning validation to demonstrate removal of active pharmaceutical ingredients and contaminants from compounding equipment.
• Support computer system validation (CSV) activities to ensure electronic systems meet 21 CFR Part 11 compliance.

• Collaborate with engineering, QA/QC, manufacturing, and IT teams to integrate new systems, troubleshoot issues, and ensure compliant implementations.
• Train pharmacy and operations staff on validated systems and procedures.

• Participate in continuous improvement initiatives by evaluating validation gaps and identifying opportunities for process and documentation enhancements.
• Support efforts to maintain and improve environmental controls, pressure differential systems, HEPA filtration, and sterility assurance.

• Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, Industrial, or related field) or a science-based discipline.
• 5+ years of experience in validation, quality assurance, or…