Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company, is a leading manufacturer of recombinant proteins. Our vision is to provide a superior and affordable source of recombinant proteins to the academic and industrial scientific research communities. Our team are a passionate group from diverse backgrounds. Our headquarters and state-of-the-art, manufacturing facility is located in Warminster, Pennsylvania. Founded in April 2006, we joined Fujifilm Group in March 2022 and are rapidly expanding our operations.
We are hiring an Aseptic Production & Vialing Technician. The Aseptic Production & Vialing Technician is responsible for final product process and vialing under aseptic conditions.
Preferred experience working in a clinical scale aseptic manufacturing environment, or equivalent
Good written and oral communication skills, including proficiency in MS Office and Abode Suite.
Proven teamwork and organizational skills, including demonstrated leadership ability
Ability to function independently
Experience in the hands-on use of equipment and processes to manufacture sterile products
Experience visually inspecting life science products
Experience operating analytical balances
Good pipetting techniques
Thorough knowledge of and experience working with cGMP and documentation principals for the manufacture of sterile products, or similar highly regulated environment
Passion for working within a team environment.
Strong knowledge of aseptic techniques and sterility assurance in aseptic processing
Basic knowledge of microbiology as it relates to sterile manufacturing
Position requires being on your feet the majority of the day, working on different floors, mobility is a must
Set-up, operate, and disinfect pharmaceutical manufacturing equipment including autoclaves, automated pipette systems, cappers, inspection systems, and lyophilizers
Perform sanitization, disinfection, and cleaning of equipment, barriers, and GMP areas
Perform routine troubleshooting and corrective/preventative maintenance on process equipment
Visually inspects biological products
Write and maintain standard operating procedures (SOPs) for manufacturing equipment
Assist with validation, change controls, and quality investigations
Performs assigned Line Clearance activities
Assist Product Teams in process development with issues related to aseptic processing technology or sterile manufacturing equipment
Provides technical training for new or less experiences team members
Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.