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Quality Validation Specialist

Los Alamitos, California

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-professionals.

​​About the Role:

The Quality Validation Specialist will be responsible for the review and participation in qualification activities to ensure the facility, equipment, and utilities are qualified for usage as per design. The expectation of this position, an individual will support the validation program by writing, executing, or providing oversight for detailed protocols and reports. Document the validation activities of the facility systems, equipment, and utilities in compliance with the appropriate regulatory agency validation requirements

This position will also participate in communicating validation activities during audits by customers and regulatory authorities. The position requires executing roles and responsibilities with minimal supervision and the ability to identify validation requirements and analyze and resolve the unique situations presented in the commissioning and qualification of a sterile injectable facility

You Will:

  • Support IQ/OQ and/or PQ activities, re-qualification, enrolment or commissioning for the facility, HVAC systems, ISO 5, 6, 7 clean rooms, utilities, and equipment for sterile GMP manufacturing operation.
  • Responsible for creating, updating, and maintaining associated documentation and reports relevant to the project.
  • Anchor, execute and/or review validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA, and validation exceptions/deviations
  • Schedule and execute validations as per standard operating procedures (SOP) and regulatory guidelines
  • Participate in validation related investigations
  • Champion and lead the continuous improvement efforts on every aspect of validation
  • Assist with resolving the issues arising from internal quality assessments/audits, regulatory inspections, and notified body.
  • Drive the efforts to close inspection issues, and findings by preparing appropriate responses and corrective actions. 
  • Foster cross-departmental relationships (QC, materials management, manufacturing, QA, and site leadership) by representing validation at team meetings
  • Employ good documentation practices (GDP) when recording data, maintaining archives and drafting or reviewing documents
  • Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry-standard procedures

You Have:

  • B.E / B. Tech – Mechanical/Chemical from reputed University OR Equivalent
  • Minimum of 3-5 years of total professional experience in pharmaceutical facility validation and qualification of new facilities for Sterile Manufacturing and packing. 
  • Review and implementation of clean Utility qualification from scratch 
  • Review and execution of HVAC system for sterile Plants
  • Basic Knowledge of Electrical, Instrumentation, and Process Engineering 
  • At least 5 years of relevant work experience in cGMP validation of facility, equipment utilities in, pharmaceutical or biotech industry 
  • Ability to work independently or with minimal managerial support
  • Must have a working knowledge about cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, data integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (electronic records and electronic signatures), industry good practices for Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) and SOPs
  • Requires strong interpersonal verbal communication and technical writing skills
  • Strong technical background in the area of process, utilities, and engineering is preferred
  • Working knowledge of industry regulations, standards, and baselines from FDA, EU-GMP, and WHO regulations, ISPE, or any other relevant regulatory agency
  • Proven track record of audit preparation and readiness with quality, compliance, and safety
  • Proven knowledge in the development, and verification of commissioning/qualification plans such as IOC, URS, FS, FAT, SAT, DQ, IQ, OQ, PQ, etc.
  • Proven track record of applying GMP regulatory requirements and engineering best practices.
  • Ability to manage priorities, deliverables, and schedule milestones

 

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.

 

Outlined below is a reasonable estimate of H&H’s compensation range for this role for US-based candidates. If you're based outside of the US, your recruiter will be able to provide you with an estimated salary range for your location.

The actual amount will take into account a range of factors that are considered in making compensation decisions, including but not limited to skill sets, experience and training, licensure and certifications, and location. H&H also offers a comprehensive Total Rewards package that may include an equity grant.

Consult with your Recruiter during any potential screening to determine a more targeted range based on location and job-related factors.

An estimate of the current salary range is

$100,000 - $110,000 USD

We are focused on 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 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.

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At Hims & Hers, we seek to establish an inclusive environment and are committed to building a team that reflects the unique perspectives, life experiences and varying backgrounds of the diverse populations that make up our customer base. To help us ensure we are meeting our equal employment obligations under U.S. employment law and identify areas of improvement in our process, we invite all U.S.-based candidates to complete the following demographic questions (if you are based outside of the United States, please select “I don't wish to answer”). 

 

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