Aseptic Production & Vialing Technician
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.
At Shenandoah, rather than strive to be the largest, we strive to be the best. We are compassionate in our work, driven by integrity and dedicated to a superior standard of excellence. It is important to us to create a working environment for our employees that is filled with respect, humor and gratitude so we can give our very best to our customers.
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
Experience / Education:
- High school diploma or equivalent
- 2 to 3 years relevant work experience
- Knowledge of aseptic techniques
- Knowledge of clean room operations
- Knowledge of working in a GMP environment
- Ability to speak, write and read English fluently
- Good oral and written communication skills
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.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.