Department: Azzur Training Center - Raleigh, LLC
The Aseptic Trainer’s primary role is to support day-to-day activities within the Training Center, including supporting all functions related to creating and delivering training content with a focus on exceptional customer service. This individual will also support the Manager/Director of Training with the implementation of progressive competency-based technical training programs, ensuring consistency, compliance, and effectiveness within and across internal and external clients. Additionally, the Training Specialist will function as part of the training team to create, or update, training presentations and supporting material (i.e. procedures, visual aids, and hands on activities) to ensure compliance with industry best practices. This individual will also be responsible for maintaining client specific curricula and training portfolios. Training may take place in classrooms or cleanrooms, which requires the ability to successfully gown and work in an aseptic environment. Travel may be required to support client training projects. Additional responsibilities to be assigned as determined necessary.
HS diploma / GED required.
Bachelor’s degree preferred with a minimum of 5 years of Pharmaceutical / Biotech industry experience, including aseptic hands-on experience.
In lieu of a degree, candidates with a suitable number of years’ experience will be considered. 10+ years of industry experience in a Pharmaceutical / Biotech industry, with at least 2 years of hands on experience in aseptic manufacturing / processing environment, is preferred.
Required Work Experience:
5+ years of experience in cGxP environment, with demonstrated capability to train others.
2+ years of direct / hands-on experience working in an aseptic manufacturing environment (i.e. manufacturing, laboratory testing, etc.).
Direct experience training personnel in an aseptic environment is highly desirable.
Strong knowledge of Federal Regulations, U.S. Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMPs) and other applicable industry guidance documents.
Extensive knowledge in aseptic gowning, aseptic manufacturing, and/or other aseptic techniques.
Familiarity with cleanroom processes including Cleanroom cleaning and maintenance, logbook completion, and industry legislation and guidance documents. Preferred Experience/Knowledge:
Direct experience and working knowledge of aseptic techniques and supporting equipment, including but not limited to: Isolators, BSCs, Laminar Air Flow Hoods, and/or RABS.
Experience performing aseptic manipulations and interventions.
Skills (Inc. Typical Mental Demands):
Must be fluent in English.
Comfortable presenting in a classroom setting to large groups.
Proficient in Microsoft Office: Word, Excel, PowerPoint / LMS and Google.
Must be able to successfully gown for aseptic operations and pass gowning qualification.
Must be able to work in an aseptic environment in gowning attire for extended periods of time (2 – 4 hours).
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations in English.
Ability to write reports, business correspondence, and procedure manuals. Ability to translate procedural information into training materials.
Ability to effectively present technical information in one-on-one and in group situations.
Able to generate accurate and complete documentation utilizing cGDocP and cGMP principles.
Ability to follow instructions and prioritize assignments while working on various projects simultaneously.
Ability to respond to questions from internal/external customers/vendors at all levels including management.
Ability to interpret a variety of instructions furnished in written, oral, and diagram or schedule form.
Strong team player
Excellent customer service/client relations
Attention to detail
Can work productively, independently, and with minor supervision
Self-motivated, flexible, dependable, and available
Excellent organizational and time management skills
Ability to travel as required for project assignments
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers, and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
From Discovery to Delivery™, Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.