Manager /Senior Manager PackagingLocation Cork, Ireland
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.
Manager/ Senior Manager, Packaging
The Packaging Manager will have responsibility for the day to day running of Packaging Operations on the Shanbally site. S/he will be responsible for leading key projects related to the Packaging facility such as introduction of new lines, equipment and transfer in of new products. The Snr. Packaging Manager will work in a team environment with an emphasis on safety and quality and with a commitment to continuous improvement.
A high level of initiative, energy, and collaboration are key role requirements, as well as excellent leadership and organizational skills and effective engagement with stakeholders
- Maintain and develop a culture focused on safety and quality within the Packaging team.
- Lead the Packaging team to deliver uninterrupted supply of commercial product.
- Partner closely with and influence cross-functional departments such as QA, Validation, Planning and Scheduling to ensure product is delivered on time, right first time.
- Manage the day-to-day operational activities within the Packaging suite with emphasis on quality, safety and efficiency.
- Ensure training, batch records and SOPs are current and compliant.
- Ensure Shanbally Packaging performance, capability and capacity is clearly communicated to the S&OP process
- Lead department preparation for and participation in regulatory inspections and safety inspections.
- Partner with serialisation SMEs to ensure Shanbally Packaging is ready to meet changing global requirements.
- Proactively drive continuous improvement and lean initiatives within the Packaging suites.
- Lead and support the investigation and resolution of process investigations, ensuring appropriate and effective CAPAs are put in place.
- Support product and SKU launch activities.
- Support tech transfer projects into Shanbally Packaging.
- Represent Shanbally Packaging in Packaging Network strategy assessments and lead relevant analysis required
- Identify and drive capacity increase projects within the department.
- Identify, recruit, mentor and develop the Packaging team to operate and sustain the packaging facility at Shanbally.
- Implement high performance team behaviors and practices leading to operational excellence.
- Own the Budget planning and headcount planning for the department
- Establish, monitor and report on Packaging Performance
A relevant third level qualification in Science, Engineering, Business or related discipline.
EXPERIENCE AND SKILLS:
- At least 5 Years’ Experience working in a GMP Operations Management Role.
- Packaging Experience would be beneficial but is not essential.
- Demonstrated ability in leading a team and successfully influencing team performance.
- Strong demonstrated ability in the area of communication and strong ability to interact with cross-functional teams.
- Experience with Regulatory Inspections and direct interaction with regulatory inspections.
- Experience with CAPA, FMEA and RCA tools is a highly regulated operations environment.
- Creative problem-solving skills, with the ability to make decisions and take necessary actions.
- Track record of embedding a strong quality and safety culture.
- Strong organizational skills, as well as the ability to manage multiple priorities.
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.