Validation Manager

• 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 hims.com/about and hims.com/how-it-works
• . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals
• .
• Hims & Hers Health, Inc. (better known as 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 revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space. Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.
• 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

hims.com

and

forhers.com

, or visit our

investor site

. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professional

About the Role

• We are seeking a Validation Manager to lead the onsite Validation Engineering Team supporting Dispense and Fulfillment, Non-Sterile Compounding, and Sterile Compounding areas in our Ohio facility. This individual will lead the day-to-day validation operations as well as provide technical expertise for a growing compounding pharmacy. This role plays a critical part in ensuring equipment testing, change control, equipment and facility requalification, and new product introductions across all facilities.
• The ideal candidate will lead a small, agile group of experts as well as provide their own technical expertise for processing areas.
• This role reports to the network-level Industrial Engineering Manager as part of the larger Industrial Engineering organization.
• This role will be responsible for 2-3 direct reports.

You Will

• Team Leadership
• Lead the day-to-day operations of the Validation Engineering Team, providing onsite presence and guidance for mid- to junior-level staff.
• Serve as the main point of contact for cross-functional groups onsite. Respond to and coordinate emergency response, delegating tasks where appropriate.
• Develop and maintain validation policies and procedures in alignment with site and company standards, ensuring compliance with all relevant regulatory requirements.
• Serve as the business owner for critical validation systems and projects.
• Own and manage the validation department budget, including capital and expense planning, contractor spend, and project cost tracking in alignment with site and network financial targets.
• Hire FTE team members and contractors as needed to facilitate necessary project work.

Technical Expertise

• Serve as a local SME for all validation activities executed onsite.
• Coordinate onsite support of functional areas by working closely with peer groups to identify necessary validation activities and execute approved project plans in an efficient manner.
• Understand all regulatory requirements to effectively manage risk. Serve as a key advisor to site operations, applying knowledge to avoid potential product quality roadblocks.

System Support

• Support installation, commissioning, and qualification of all assigned systems and equipment.
• Understand validation scope and anticipate requalification activities based on proposed changes.
• Administer the annual requalification program for the site, ensuring 100% compliance with schedule and regulatory commitments.

Compliance & Documentation

• Ensure systems meet relevant regulatory documentation standards.
• Maintain validation documentation (e.g., IQ/OQ protocols), URS, FRS, and SOPs related to all applicable systems.
• Support internal and external regulatory audits, serving as an SME for critical audit responses.

Cross-functional Support

• Interface with maintenance, operations engineering, QA, and operations teams to support ongoing compounding and fulfillment operations.
• Work with vendors and contractors during new system implementation or upgrades, as well as ongoing system support.

You Have

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related technical field.
• 8-10 years of experience in Engineering/Validation or a similar support group in regulated environments (pharmaceutical, biotech, medical device, or cleanroom facilities), with a minimum of 2 years in a supervisory or team lead capacity with direct report responsibility.
• Demonstrated experience managing, developing, and performance-reviewing direct reports in a technical engineering environment, including hiring, onboarding, and coaching mid- to junior-level staff.
• Demonstrated experience owning a departmental or project-level budget, including forecasting, managing contractor and capital spend.
• Extensive validation experience supporting ongoing pharmaceutical manufacturing activities, including authoring studies, executing protocols, and completing final documentation.
• Working knowledge of sterile filling, tableting, liquid filling, powder blending, package handling, facility operation, and facility design.
• Comprehensive understanding of regulatory standards including 21 CFR, EU Annex 1, USP 797, and USP 800, with expertise in environmental monitoring, worker safety guidelines, and negative pressure room specifications for hazardous compounding.
• Working knowledge of electronic quality management systems (QMS) such as Veeva, MasterControl, or equivalent platforms for validation lifecycle management, change control, and deviation tracking.
• Strong analytical, problem-solving, and communication skills, with the ability to work independently and across cross-functional teams to troubleshoot complex technical issues.
• Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.
• Willingness to travel up to 20% as required, including vendor FATs, cross-site validation support across network facilities in Arizona, Ohio, and international sites, and punch list resolution during system commissioning.
• Hands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of pharmacy regulatory standards.
• Strong written and verbal communication skills, with the ability to work effectively across cross-functional teams.
• Our Benefits (there are more but here are some highlights):
• We are dedicated to building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
• Hims & Hers is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. Hims & Hers considers all qualified applicants in accordance with the San Francisco Fair Chance Ordinance.

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 you're excited about this role, we encourage you to apply—even if you're 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 [email protected] 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.
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