Learning Specialist, Aseptic Processing

The role

This person will lead technical training and development for aseptic processing personnel within sterile compounding facilities. They will act as a subject matter expert for aseptic technique, cleanroom operations, and sterile compounding compliance.

What you will do

• Develop, deliver, and improve training programs for aseptic technique, cleanroom behavior, gowning, sterilization, visual inspection, and compounding procedures.
• Conduct hands-on training and competency assessments in simulated and live sterile compounding environments.
• Lead ongoing competency evaluations and retraining initiatives.
• Collaborate with Quality Assurance and Operations to identify training-related root causes and implement corrective actions.
• Develop and maintain training SOPs, competency checklists, and aseptic simulation and media fill validation documentation.
• Maintain up-to-date training records in compliance with FDA 503A/503B requirements and USP guidelines.
• Integrate new industry best practices and standards into training curricula.
• Support audit readiness by ensuring training documentation is complete and inspection-ready.
• Maintain floor presence in sterile compounding environments to monitor compliance and identify gaps.

Required qualifications

• High school diploma, GED, or equivalent
• Active CPhT (Certified Pharmacy Technician) certification
• Minimum 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding environments with hands-on aseptic processing responsibilities
• Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff
• Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations
• Proven expertise in cleanroom protocol, contamination control, gowning, aseptic techniques, and compounding documentation practices
• Strong facilitation and presentation skills
• Familiarity with regulatory compliance, training documentation, and Good Documentation Practices (GDP)
• Experience developing training SOPs, competency checklists, and aseptic simulation and media fill validation programs
• Strong communication skills

Nice to have

• Bachelor's degree in a scientific, pharmaceutical, or related field

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO
• Company holidays
• Quarterly mental health days
• Comprehensive health benefits including medical, dental & vision
• Parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

About the company

Hims & Hers is a health and wellness platform that provides access to personalized, affordable healthcare. It is a public company traded on the NYSE.