BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
Biomarin has recently received approval to install an additional secondary packaging line at the Cork facility.
The addition of a new syringe assembly and labelling line will bring to five, the number of products which will be secondary packaged at the Cork Facility. These products employ a range of packaging formats and technologies such as; labelled vials, tablets in bottles, Device Kit Assembly and pre-filled syringes.
This is an exciting opportunity to join the expanding secondary packaging and labelling team.
The ideal candidate will be able to demonstrate a proven track record in a quality-focused operational environment where attention to detail and commitment to the task at hand is key. Previous GMP secondary packaging experience is required with a strong preference for candidates with syringe assembly and labelling background.
Reporting to the Packaging Manager, the successful candidate shall work as part of a team of Packaging Technicians to complete the packaging of finished product within time out of refrigeration constraints for onward distribution to patients.
The candidate will be required to work closely within a cross-functional team including other Packaging Technicians, Packaging Equipment 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
MAIN AREAS OF RESPONSIBLITY:
- Operate and monitor equipment on the packaging lines. Including the set-up, challenging and adjustment of equipment and vision systems in line with GMP and Standard Operating Procedures.
- Perform changeovers/setups and troubleshooting on the line. Identify issues on the equipment and provide support to the Equipment Technician to help resolve issues. A high mechanical aptitude and capability is desired.
- Follow standard work and role cards developed for packaging operations and develop future revisions.
- Pro-actively identifies compliance risks and takes appropriate preventative actions.
- Complete detailed batch record and GMP documentation entries which are accurate, attributable, complete, legible & clear, original, timely & prompt.
- Responsible for the writing, updating and execution of Batch Records, SOPs and other GMP Documentation.
- Support packaging equipment commissioning and qualification.
- Proactively lead and support continuous improvement and Lean initiatives within the packaging suite.
- Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs, etc. as required.
- Use right first time and lean manufacturing practices leading to operational excellence.
- Participate in/Lead cross functional team Initiatives.
- Demonstrate commitment to a high level of safety awareness within the packaging operations team.
- Maintain an exemplary personal training record.
- Perform housekeeping duties
- Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards.
EDUCATION AND EXPERIENCE
- Previous experience in a highly regulated secondary packaging operation is required.
- Previous experience of syringe assembly and labelling is highly desirable
- A high mechanical aptitude and capability is desired along with technical experience.
- Candidates that can demonstrate a keen sense of focus and attention to detail when fulfilling exacting and repetitious tasks will have a distinct advantage.
- Must be conscientious and possess strong teamwork and interpersonal skills. Strong communication and problem solving skills are highly valued.
Note: 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.