Aseptic Control LeadLocation Cork, Ireland Apply
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.
We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. With the introduction of a new Drug Product, Fill Finish Facility, and Sterility Testing capability, utilising Isolator Technology and Vaporised Bio-decontamination Systems we require an experienced Aseptic Control Lead.
The primary role of the Aseptic Control Lead will be to support Drug Product Filling Operations by providing Microbiological, Technical and Compliance support to ensure Aseptic Control of DP Fill Finish Operations and testing.
SKILLS/ KNOWLEDGE/ BEHAVIOURS
The role includes but is not limited to the following:
- Implementation and Maintenance of the Contamination Control Strategy and associated risk assessments
- On the floor support and Subject Matter Expert to partner with DP Operations to enhance bio-decontamination prevention and control
- Identifying and Leading Process Improvements
- Support training on cleanroom behaviours and aseptic processing is isolator systems
- Troubleshooting contamination events/ investigations – eg. Media Fill, Bioburden, Sterility, Environmental Monitoring, Utilities
- Experience in Change Controls, Investigations (RCAR) and deviations, Quality Risk Management
- Experience in Drug Product Fill Finish Facility
- Knowledge of Isolator Filling systems and VHP decontamination
- Monitor and Support Aseptic Process Simulations Media Fills
- Support Regulatory Audits
- Proactive team member looking for opportunities to improve current systems and process
- Ability to collaborate with other BioMarin departments (Drug Product Operations, Quality Assurance Validation, Facilities, etc.)
- Excellent communication skills both written and verbal
- Excellent technical writing skill and experience in writing SOPs/ QRAs
- Experience with electronic systems – Veeva, Trackwise, MES
- Takes personal responsibility for timely delivery of tasks to the highest quality
- Self-motivated and ability to work under pressure
- Successful track record in achieving goals as part of a team within a growing, dynamic environment
B.Sc. in a scientific discipline with 5+ years of cGMP experience in a relevant Microbiological role preferably in an aseptic environment or supporting aseptic manufacturing
Good working Knowledge of the US and EU GMP and Safety Compliance regulations, eg Annex 1
• Ability to work independently and meeting established timelines.
• Comfort with coordinating the activities with other staff members.
• Comfort with working in a team environment
• Previous experience interacting with Regulatory agencies desirable
Reports to Quality Control Lead. Interacts with several departments, including but not limited to Drug Product Operations, Validation, Quality Assurance, Maintenance, Engineering, and Manufacturing Sciences.
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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.