Pharmaceutical Validation Engineer
Pharmaceutical Validation Engineer
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1 Vacancy
Job Description
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 were 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 companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: 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. Location and shift: This position is located in New Albany OH. You must work onsite Monday-Friday. The shift is 9:00am -5:00pm Eastern Time. 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. Bachelors 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. 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 We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement.
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.You Will:
Validation Development & Execution
Validation Activities & Data Analysis
Documentation & Regulatory Compliance
Commissioning & Qualification (CQV)
Process Cleaning and Computer System Validation
Cross-functional Collaboration
Continuous Improvement
You Have:
Our Benefits (there are more but here are some highlights):
Employment Type
Full-Time
