Serialization & Packaging Specialist - MFG728
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Serialization & Packaging Specialist - MFG728Apply Now
Be the single point of contact for serialization requirements implementation:
- Participate to global unique product identifiers team meetings, identify new requirements and report to the site.
- Perform impact assessment due to serialization requirements change or new regulation.
- Work closely with automation, operation, packaging, validation to establish the impact assessment, validation and implementation requirements
- Work with stockholders to identify packages, develop plan and lead the project execution within identified milestones and budget.
- Anticipate and proactively address simple or complex bottlenecks or issues. Recommend and implement enhancements to projects by soliciting input from project members and Global Program lead.
- Act as reviewer and approval of the global users’ requirements specification.
- Develop and maintain local SOP’s related to serialization.
- Support the site on problem solving related to day to day serialization activities.
- Develop and maintain project metrics and feedback measurements to ensure professional delivery of projects and proper communication to UPI lead and stakeholders.
- Ensure timely change control tasks execution and closer.
- Able to support at the detailed level and prepared to support the team by taking on some actions
Assist packaging design team on planification, execution of all projects related to design and or material change:
- As project owner, develop detailed Gantt chart with the stakeholders and ensure timely execution.
- Ensure timely change control tasks execution and closer.
- Coordinate the project tasks execution with various departments, labeling, packing, packaging, quality, purchasing, validation.
- Identify and mitigate risks associated with assigned projects by developing mitigation plans, following set escalation plans as necessary and proactively monitoring risks throughout the project.
- Lead, and execute all aspects of a project. Accountable for delivering on specific performance indicators, including but not limited to:
- Documentation cycle time (Packaging Component Specifications, Bill of Materials, Technical Protocols and Reports, Material Qualification, Regulatory Filing Support Documentations, etc),
- Able to support at the detailed level and prepared to support the packaging design team by taking on some actions.
Support packaging design group and operation in the following activities:
- Represent Packaging Design as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Labeling and other internal or external customers on new and existing products introductions.
- Support the execution and implementation of programs to improve the quality and/or efficiency of commercial packaging operations.
- Providing technical support to quality, manufacturing/packaging operations, supplier relations management.
- Execute various duties to support department and/or site, such as Change Requests, Non-conformance/CAPA, department initiatives, learning activities and various operational improvement programs.
- support the development, launch and life cycle management of secondary and/or, tertiary packaging components.
- Assisting or leading in package trial runs, project start-ups, resolving manufacturing issues, supporting continuous improvement projects.
- Participate to the development of packaging technical spec, material qualification protocol and report.
- Packaging, Automation, Mechanical Engineering degree – minimum 10 years of experience.
- Experience in working in Biopharmaceutical or highly regulated and compliance industry
Key Skills, Abilities, and Competencies
- Complete, in-depth understanding of all aspects of serialization technology and process.
- Experience in managing complex projects in a multinational environment with multiple stakeholders.
- At least 3+ years Project Management experience required.
- Advanced user in project management tools (e.g. MS Project).
- Must be both strategic and task-oriented/ issue resolution focused.
- Able to support at the detailed level and prepared to support the team by taking on some actions.
- Technical knowledge on packaging technology is required.
- Highly developed interpersonal skills are required to effectively communicate with all levels within the organization.
- Excellent organizational skills and attention to detail.
- Ability to simultaneously manage and prioritize multiple requests required.
- Fluent in French and English both spoken and written
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0041545