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Who We Are
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.
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.
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.
Packaging, Bioprocess Specialist - Shanbally, Cork - Closing date 18th August 2023
The Bioprocess Specialist – Packaging Operations reports to the Packaging Operations Manager and works in a team environment that will be committed to continuous improvement, process understanding, personal development and demonstration of production techniques that will result in agile and compliant packaging operations.
Main areas of responsibility
- Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
- Own, investigate, write and approve associated deviations as well as support & coach Packaging Technicians in these functions – ensure adoption of ‘zero late’ mentality in meeting timelines.
- Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
- Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems
- Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviours.
- Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
- Supervise, and perform as needed, employee training in Packaging Operations.
Skills
- Demonstrated experience working with device assembly and secondary packaging operations in a cGMP environment.
- Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
- Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
- Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
- Experience with regulatory inspections.
Equipment
- Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
- Experience in operation of labelling, assembly and serialisation equipment highly desirable.
Education
- Degree in science/engineering, operations management or industrial engineering required
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
Experience
- At least 3 years experience in a regulated manufacturing environment with excellent knowledge of packaging operations
- Experience in device assembly, secondary packaging and labelling and serialisation beneficial
- Demonstrated ability to partner with other functional groups to achieve business objectives
- Strong knowledge of cGMPs (US & EU), ISO, ANSI and other regulatory agency standards and requirements applicable to packaging operations
- Experience of successfully contributing to a start up operation highly desirable
- Strong communication and interpersonal skills – oral, written and formal presentation skills
- Creative problem solving skills
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.
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