Pharmaceutical Aseptic Processing Trainer

Hims & Hers•Gilbert, AZ

13d

About The Position

We are seeking a highly experienced and knowledgeable Pharmaceutical Aseptic Processing Trainer to lead training and development programs for aseptic processing personnel within our sterile compounding facility. This role plays a critical part in ensuring that compounding staff are well-equipped with the technical knowledge and practical skills required to maintain compliance with cGMP, USP <797>/<800>, and FDA 503A/503B regulatory requirements. The ideal candidate will bring deep subject-matter expertise in sterile pharmaceutical manufacturing and aseptic processing, with a proven track record in hands-on training and evaluation of compounding operators. This position will collaborate closely with Quality Assurance, Operations, Learning, and Compliance teams to maintain the highest standards in product integrity and patient safety.

Requirements

Minimum 5 years of direct experience working in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding environments, with hands-on aseptic processing responsibilities in manual and semi-automated filling techniques.
Bachelor’s degree required, preferably in Pharmaceutical Sciences, Microbiology, Biology, Chemistry, Quality Assurance, or a closely related field.
Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff. Experience delivering hands-on training in both individualized (1:1) and group/classroom environments preferred.
Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations.
Proven expertise in cleanroom protocol, contamination control, gowning, and aseptic techniques
Demonstrated experience applying quality assurance techniques such as root cause analysis, deviation/investigation management, CAPA processes, and documentation best practices.
Experience in developing training SOPs, competency checklists, and aseptic simulation media fill validation.
Strong communication skills with the ability to teach complex topics to diverse audiences.

Nice To Haves

Background in auditing or regulatory inspections (e.g., FDA, BOP, PCAB) is a plus.

Responsibilities

Develop, deliver, and continuously improve comprehensive training programs for aseptic technique, cleanroom behavior, environmental monitoring practices, gowning, sterilization, visual inspection and compounding procedures.
Conduct hands-on training and assessments for new hires and experienced staff in both simulated and live sterile compounding environments.
Lead ongoing competency evaluations and retraining initiatives to ensure continuous compliance with regulatory standards and internal SOPs.
Collaborate with QA and Operations to investigate deviations, identify training-related root causes, and implement corrective actions through targeted education.
Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements, USP guidelines, and cGMP practices.
Stay informed on regulatory changes and integrate new industry best practices into training curricula.
Provide mentorship and technical guidance to aseptic operators and pharmacy technicians to elevate team performance and product quality.
Ability to work primarily day shift hours, with flexibility to cover night shift hours as needed to support our 24/7 pharmacy operation.