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hims & hers · 1 day ago

Validation Engineer

New Albany, OH

Full-time

Hybrid

Senior Level

5+ years exp

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. The Pharmaceutical Validation Engineer will support validation activities across sterile and non-sterile compounding operations, ensuring compliance with regulatory standards and maintaining validation readiness.

Health CareLifestyleMen'sWellnessWomen's

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

Qualification

CommissioningQualification (CQV)Process ValidationCleaning ValidationComputer System Validation (CSV)CGMP ComplianceFDA 21 CFR Part 210/211Risk AssessmentsValidation Protocols (IQ/OQ/PQ)Microsoft Office SuiteAnalytical SkillsOrganizational SkillsProblem-Solving SkillsCommunication SkillsCross-Functional CollaborationLeadership Skills

Required

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, 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)

Willingness to travel as required to equipment FATs, vendor sites etc