Quality Validation Specialist

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 Quality Validation Specialist will serve as the subject matter expert (SME) and technical owner of the site validation and calibration programs within a sterile cGMP manufacturing environment. This role is responsible for authoring, executing, and overseeing validation protocols, reports, and supporting documentation to ensure facilities, utilities, systems, and equipment are qualified and compliant with regulatory standards.

The successful candidate will bring deep validation expertise, the ability to build and continuously improve systems, and a proven track record of technical problem-solving in sterile pharmaceutical operations. This individual will play a critical role in ensuring inspection readiness, regulatory compliance, and continuous improvement across validation programs.

You Will:

• Lead and support commissioning, qualification, and validation (IQ/OQ/PQ) activities for facilities, HVAC, ISO 5/6/7 cleanrooms, utilities, and equipment in a sterile cGMP environment.

• Author, review, and execute validation documentation including protocols, reports, project plans, risk assessments, CAPAs, deviations, and change controls.

• Serve as SME for validation within the change control process, providing technical oversight and guidance across cross-functional teams.

• Own and manage the site calibration program, ensuring adherence to schedules and regulatory requirements.

• Collaborate with and oversee external validation consultants, including scoping, scheduling, and reviewing deliverables.

• Develop, implement, and drive continuous improvement of validation and calibration systems, applying industry best practices and regulatory standards.

• Develop and report on key metrics related to areas of responsibility, including statistical analysis as needed.

• Own quality investigations, change controls, and project related to areas of responsibility.

• Assist in developing, monitoring, and acting on process data to drive continuous improvement.

• Support audit and inspection readiness by presenting validation activities to regulatory authorities and customers; lead responses and corrective actions for findings.

• Partner with Quality, Manufacturing, Engineering, and site leadership to resolve technical issues, support process improvements, and foster a culture of compliance.

• Apply good documentation practices (GDP) and good engineering practices (GEP) in all activities.

• Maintain and demonstrate expertise in applicable regulatory requirements (FDA, ICH, ISPE) and ensure compliance with cGMP, cGxP, and 21 CFR Parts 11/210/211.

You Have:

• B.E. / B. Tech in Mechanical, Chemical, or related engineering discipline from a recognized university (or equivalent).

• Minimum 3-5 years of relevant validation experience in pharmaceutical or biotech sterile cGMP environments.

• Proven expertise in facility, equipment, and utilities qualification, including sterile manufacturing and cleanroom/HVAC systems.

• Strong technical knowledge of process, utilities, instrumentation, and engineering fundamentals and an ability to analyze and resolve situations that arise in the commissioning and qualification of a sterile injectable facility.

• Demonstrated ownership of validation and calibration programs.

• Experience with commissioning/qualification lifecycle deliverables (URS, FS, FAT, SAT, DQ, IQ, OQ, PQ).

• Working knowledge of industry regulations and guidance (FDA, ISPE, ICH Q7-Q9, Annex 11, Part 11).

• Experience supporting regulatory inspections and audits with successful outcomes.

• Strong background in change controls, investigations, and root cause analysis methodologies.

• Experience with the application of risk management tools and risk-based decision making.

• Experience with statistical process control (SPC), leading process improvement projects, and continuous process verification (CPV) preferred.

• Experience working with and/or qualifying automated equipment preferred.

• Excellent technical writing, communication, and cross-functional collaboration skills.

• Demonstrated ability to independently prioritize, problem-solve, and deliver results in a fast-paced environment, with minimal supervision and high accountability.

• Knowledge of Sterile formulation engineering

• Knowledge of USFDA, cGMP, GLP, ISPE, ISO

• Risk Management

• Project Management

• Planning & Execution of qualification and calibration activities

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

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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