Sterile Manufacturing Technician
The Sterile Manufacturing Technician will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support.
This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.
BioMarin has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational skills.
attend equipment FATs, develop SOPs and batch records, generate training and qualification programmes, support equipment and process validation activities.
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 will also have responsibility for operation of the parts washer and autoclave. Responsibilities also include root cause analysis of equipment and process problems, and implementing effective solutions, including preventive and / or corrective actions.
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.
Reporting to the Sterile Drug Product Operations Manager, the successful candidate shall 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 :
This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.