Reporting to the Packaging Project Lead, the Packaging Launch Specialist is an integral part of a collaborative team dedicated to continuous improvement, process comprehension, personal growth, and the exhibition of agile and compliant packaging operations.
- Orchestrating the introduction of new products at the site, such as the Voxzogo DCC launch.
- Overseeing multiple market launches for existing products, averaging around 50-60 launches per year, including Palynziq, Voxzogo, Vimizim, and Naglazyme.
- Representing the site at global launch forums to ensure adherence to product launch plans and production schedules.
- Demonstrating effective stakeholder management by liaising with various on-site departments and global teams (e.g., Material Operations, Capital Projects, Process Engineering, Quality, Packaging Development, Product Artwork Team, MES, etc.).
- Establishing a launch management process and utilizing Six Sigma tools to identify improvement opportunities.
- Collaborating closely with peer groups to maintain up-to-date and compliant master batch records, SOPs, training records, and other documentation in accordance with cGMP standards, ensuring consistency in manufacturing systems and practices across the organization.
- Partnering with subject matter experts to prepare and approve validation protocols, validation plans, protocol executions, and summary reports to support ongoing revalidation and validation efforts for Commercial Packaging Operations.
- Providing operational support as needed, including support for RCARs, continuous improvement initiatives, and capital projects.
- Ensuring compliance with cGMP documentation and operations.
- Demonstrating a proactive approach to safety, industrial hygiene, environmental compliance, and regulatory requirements.
- Demonstrated experience working in a cGMP environment.
- Proven ability to deliver projects within tight timelines.
- Preferred experience in Lean Six Sigma methodologies.
- Strong communication skills and the ability to collaborate across cross-functional teams.
Required Education and Experience:
- A degree in science, engineering, operations management, or industrial engineering is required.
- Six Sigma, Lean Manufacturing, or industry-specific coursework, is highly desirable.
- Minimum of 3-5 years of experience in a regulated manufacturing environment with in-depth knowledge of packaging operations.
- Proven project management expertise with a track record of meeting strict project schedules.
- Familiarity with project management tools like Excel and Microsoft Project.
- Strong understanding of cGMPs (both US and EU), ISO, ANSI, and other regulatory standards relevant to packaging operations.
- Experience contributing to the successful launch of a start-up operation is highly advantageous.
- Exceptional communication and interpersonal skills, including oral, written, and formal presentation abilities.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
For further information on this role please contact Maraleeze on 086 4410614/ firstname.lastname@example.org
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