Aseptic Compounding Process Engineer
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Job Location:
New Albany, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
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: The Aseptic Compounding Process Engineer is responsible for the design qualification validation optimization and lifecycle support of aseptic compounding processes facilities and equipment used in the production of sterile drug products. This role ensures sustained compliance with USP <797> applicable FDA and cGMP requirements and internal quality standards while driving continuous improvement in sterility assurance process robustness and operational efficiency. The position works cross-functionally with Operations Quality Validation Microbiology and Maintenance teams to support routine manufacturing new product introductions technology transfers and regulatory inspections. Work Environment Work performed in ISO-classified cleanrooms and controlled environments requiring gowning and aseptic behaviors Office-based engineering documentation and analysis work Occasional off-hours or on-call support for manufacturing operations and critical activities Aseptic Process & Equipment Engineering Design implement and maintain aseptic compounding and sterile processing operations for sterile drug products. Support selection installation qualification and lifecycle management of aseptic compounding equipment including cleanroom systems and utilities. Lead or support IQ/OQ/PQ activities for equipment facilities and processes in regulated environments. Provide engineering support for ISO-classified cleanrooms HVAC systems and critical utilities impacting sterility assurance. Sterility Assurance & Regulatory Compliance Ensure compliance with USP <797> (and USP <800> where applicable) FDA regulations and cGMP requirements. Author review and approve SOPs validation protocols risk assessments and technical reports. Support and participate in media fills environmental monitoring programs gowning qualifications and aseptic process simulations. Lead or support contamination investigations deviation management and CAPA development. Process Optimization & Troubleshooting Investigate aseptic process deviations and equipment failures using structured root cause analysis. Apply risk management tools (e.g. FMEA) to identify and mitigate risks to sterility assurance. Drive continuous improvement initiatives to improve process robustness yield throughput and compliance. Support remediation activities related to audits inspections or internal quality findings. Cross-Functional Collaboration Partner closely with Compounding Operations Quality Assurance Validation Microbiology Facilities and Maintenance. Provide technical support during regulatory inspections and audits including FDA inspections and audit responses. Support technology transfer scale-up and new product introductions including process readiness and validation planning. Documentation Training & Knowledge Management Maintain compliant inspection-ready engineering and validation documentation. Train operations and technical staff on aseptic principles equipment operation contamination control and best practices. Stay current with evolving regulatory guidance industry standards and emerging aseptic technologies. Bachelors degree in Engineering Pharmaceutical Sciences Pharmacy or a related technical field. 1-3 years of experience in aseptic or sterile compounding pharmaceutical manufacturing or regulated cleanroom environments. Working knowledge of cGMP USP <797> (and <800> where applicable) and aseptic processing principles. Hands-on experience with aseptic compounding sterilization methods (e.g. steam dry heat filtration) and cleanroom operations. Experience supporting equipment qualification process validation and lifecycle management in regulated environments. Preferred Qualifications Masters degree in Engineering or Pharmaceutical Sciences. Experience with isolators RABS single-use systems or advanced aseptic automation. Lean Six Sigma or formal risk management training. Direct experience supporting FDA inspections regulatory audits or inspection remediation activities. Key Competencies Strong technical problem-solving and analytical skills High attention to detail with a focus on data integrity and documentation excellence Effective cross-functional communication and collaboration Ability to operate in fast-paced highly regulated environments Strong commitment to quality safety and patient protection Competitive salary & equity compensation for full-time roles Comprehensive health benefits including medical dental & vision and parental leave Employee Stock Purchase Program (ESPP) 401k benefits with employer matching contribution 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 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. Required Experience: ICYou Will:
You Have:
Our Benefits (there are more but here are some highlights):
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
