Validation Engineer - AZ

Hims & Hers • Gilbert, AZ

3d

About The Position

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 <795>, <797>, <800>, 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.

Requirements

• 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 regulated pharmaceutical manufacturing, preferably in compounding environments.
• Working knowledge of USP <795>, <797>, <800>, cGMP, and FDA 21 CFR Part 210/211 regulations.
• Experience in creating, executing and documenting IQ/OQ/PQ protocols, risk assessments, and change control procedures.
• Familiarity with validation of utilities, cleanrooms, automation systems, and computer systems used in manufacturing and compounding.
• Proficiency in Microsoft Office Suite, AutoCAD, and documentation systems such as Veeva, MasterControl, or equivalent.
• Strong analytical, organizational, and problem-solving skills with attention to technical accuracy and regulatory compliance.
• Excellent written and verbal communication skills with the ability to interact across cross-functional teams.
• Demonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems.
• Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.
• Strong written and verbal communication skills, including proficiency with Microsoft Office tools (Excel, Word, PowerPoint); experience with Smartsheet, Jira, or similar platforms is a bonus.
• Willingness to travel as required to equipment FATs, vendor sites etc.

Responsibilities

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for cleanrooms, 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.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees