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.

​​About the Role:

The Compounding / Operations Validations Specialist is responsible for developing, executing, and maintaining validation protocols and reports related to compounding equipment, processes, and cleaning procedures. This role ensures that all compounding operations comply with applicable regulatory requirements, internal quality standards, and industry best practices for process validation, cleaning validation, and equipment qualification.

This role is based on site in our New Albany, OH facility.

You Will:

Process & Equipment Validation

• Draft and execute validation protocols (IQ/OQ/PQ) for solid dose manufacturing equipment such as blenders, granulators, tablet presses, capsule fillers, fluid bed dryers, and coating machines.

• Conduct validation studies for new or modified compounding processes including wet granulation, dry blending, direct compression, and film coating.

• Perform sampling and data collection to support process capability assessments and equipment qualification.

Cleaning Validation

• Develop and maintain cleaning validation protocols and reports for solid dose equipment.

• Coordinate swab/rinse sampling with laboratory and production teams; analyze and trend cleaning data.

• Ensure cleaning validation activities meet regulatory expectations and support routine revalidation efforts.

Process Validation & Tech Transfer

• Support product lifecycle validation including protocol development, execution of process performance qualification (PPQ) batches, and continued process verification (CPV).

• Participate in technology transfer activities from R&D to commercial scale, ensuring equipment and process suitability.

• Generate and maintain validation master plans (VMP), risk assessments, and validation traceability matrices.

Compliance & Documentation

• Ensure validation documentation adheres to cGMP, FDA, EU Annex 15, and ICH guidelines. Maintain compliance with USP <795>, <797>, and <800> (as applicable) and other regulatory guidelines.

• Participate in audits and inspections by providing validation records and justifications.

• Support deviations, change controls, and CAPAs related to process and equipment validation.

You Have:

Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related technical field.

• 3+ years of experience in validation within solid oral dosage manufacturing.

• Hands-on knowledge of solid dose unit operations: blending, granulation, compression, encapsulation, and coating.

• Familiarity with applicable regulatory guidelines Maintain compliance with USP <795>, <797>, and <800> (as applicable) and other regulatory guidelines. (FDA, EU GMP, ICH Q8–Q10) and validation expectations.

Preferred Skills:

• Experience with validation project management and cross-functional team collaboration.

• Proficiency in data collection, analysis, and statistical tools (e.g., Minitab, JMP).

• Knowledge of QMS platforms like TrackWise, MasterControl, or Veeva.

• Lean Six Sigma certification (Yellow/Green Belt) is a plus.

• Strong technical writing and documentation skills.

Our Benefits (there are more but here are some highlights):

• 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)

• Employee discounts on hims & hers & Apostrophe online products

• 401k benefits with employer matching contribution

• Offsite team retreats

Conditions of Employment:

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.

• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).

• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.

• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

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 accommodations@forhims.com 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 our Global Candidate Privacy Statement.