Sterile Manufacturing Technician
This role supports the start-up of a state-of-the-art flexible line using isolator technology for filling vials and syringes, and prepares the facility for clinical and commercial filling of BioMarin's biologics product portfolio.
As part of establishing sterile filling operations at the Shanbally facility, this role plays an important part in the start-up process, including tasks such as attending equipment FATs, developing SOPs and batch records, generating training and qualification programs, supporting equipment and process validation activities.
Once start up is complete, the Sterile Manufacturing Technician performs recombination and pooling of drug substance; filling line set-up and sterile filling operations, equipment and line changeovers, and sampling in accordance with approved procedures prior to visual inspection activities. This role also has responsibility for operating the parts washer and autoclave.
The ideal candidate will be able to demonstrate a proven track record in a quality-focused, operational GMP environment where attention to detail and commitment to the task at hand is key. Previous GMP Sterile Filling experience is required, with a strong preference for candidates with isolator vial and syringe filling experience in a start-up environment.
Responsibilities include performing all operational tasks related to recombination, pooling, sterile filling and visual inspection in accordance with established procedures, writing, updating and executing Batch Records, SOPs and other GMP Documentation, and completing detailed batch record and GMP documentation entries that are accurate, attributable, complete, legible & clear, original, timely & prompt.
The successful candidate will work as part of a team of Sterile Filling Technicians to complete both the manufacturing and visual inspection of sterile drug product as per the schedule for onward processing in the packaging facility. The candidate will be required to work closely within a cross-functional team including other Sterile Filling Technicians, Maintenance Technicians, Quality, Material Operations, Supply Chain and others.
This role requires flexibility with regards to work schedules. This is initially a day position, with future shift work required. Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.