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San Francisco, California Full Time Posted: Thursday, 7 December 2017
This position supports the establishment of a world-class global packaging development organization by providing technical leadership and expertise in the development, qualification and deployment of new packaging systems for sterile pharmaceutical products.
The person in this position applies extensive theoretical and cross-functional expertise, independently addresses complex problems and determines and selects methods and procedures to complete the assigned projects.
The Senior Packaging Engineer in this position manages and/or executes complex packaging projects with multiple stakeholder interfaces. They identify business needs, defines goals and develops project execution plans. They calculate the business case, asks for endorsement and executes the project. They organize the project in collaboration with the subject matter expert-departments. They define responsibilities within the scope of project organization, monitors the progress of the project and ensures compliance with costs, schedule and quality constraints. They undertake proactive measures to achieve project goals in the event of deviations from the project plan, exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results and works on complex issues where analysis of situations and data requires in-depth knowledge and understanding of the organization.
They establish priorities, timelines and deliverables, provides the necessary leadership, technical expertise and tactical execution to ensure packaging life-cycle efforts on a global level (design, development, testing, qualification and maintenance of global secondary and tertiary packaging components and processes) to meet business, regulatory and technical requirements.
The Senior Packaging Engineer in this position works under limited direction and establishes his/her own work priorities and timelines. They leverage a centralized approach to promote compatibility and standardization between a network of in house and contract packaging facilities. The success of this function requires effective collaborations with Early and Late Stage Pharmaceutical Development, Contract Manufacturing, Marketing, Supply Chain, Manufacturing, Packaging Operations, Regulatory, etc., and by providing technical expertise, project leadership and on-going support to resolve issues and introduce new technologies and processes.
Scope of this responsibility includes the development and qualification of global packaging solutions. Projects in the areas of clinical packaging, product launches and marketed products can be assigned.
Primary Responsibilities/Accountabilities:
  • Develop and qualify global secondary and tertiary packaging solutions for sterile products
  • Qualification of global packaging solutions in line with the current valid requirements (e. g. Development of test protocols and reports, execute IQ, OQ, and PQ etc.)
  • Maintenance of global packaging solutions (e. g. maintain global specifications, support change control records, provide impact assessments, execute requalification etc.)
  • Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements
  • Ensure compliance with international regulations (GMP, SHE, pharmacopoeias, authorities, requirements) and adherence to relevant Roche Quality Directives, Procedures, Guidelines, GSP s
  • Support the Contract Management Organization (CMO organization with the evaluation and selection of new CMO s and provide input about the packaging relevant technical capabilities of existing CMO s
  • Support external quality and global procurement with the selection and qualification of globally relevant suppliers
  • Manage packaging development project/topics or packaging development sub-projects in global team. Drive the packaging topics to meet predefined timelines. Drive the process to establish and agree on packaging requirements and meet agreed technical requirements, agreed timelines and financial budget contains according agreement
  • Works autonomously on complex tasks or several parallel tasks and projects. Sets priorities and fulfills deadlines. Majority of projects have strategic relevance for the organization
  • Support contract-manufacturing sites (CMO s) with regard to development, qualification and implementation of secondary and tertiary packaging solutions as well as packaging & transport processes for sterile products
  • Artwork proofing and approval for CMO s
  • Successful collaboration with internal and external stakeholders (Global packaging development non-steriles, DTech, CMO, Procurement, Device development, primary packaging development, QA, Small molecules sites, Biologics sites, etc.)
  • Provide packaging technical support on global technical development teams (TDT), technical product teams (TPT), product technical teams (PTT) and global device development teams for clinical packaging, commercial product launches and post launch maintenance for global packaging solutions
  • Facilitate and foster exchange between different Roche packaging sites related to packaging topics like future trends, new technologies, process improvements etc. Represent the packaging development organization as a prime contact on initiatives, projects and as a subject matter expert
  • Bring and develop packaging expertise into the organization and function as a key communication interface between Sales/Marketing, Manufacturing, Contract Manufacturing, Quality, R&D and suppliers in the development and execution of technical packaging initiatives. Interacts with senior internal and external leaders on packaging strategies, trends, investment needs and explains the impact for the organization
  • Communicate effectively and in a timely manner. Regularly communicate project status, critical issues and events of the project to the project leader, stakeholders and line function. Ensure that management is informed ahead of time when goals are not fully achieved
  • Active and constructive contribution to the gPKD Team. Support team spirit, team alignment, share responsibility, share risks in the team beyond the function and overall. Develop knowledge for the organization and share the gained know how with the team members. Focuses and motivates team members toward a common goal and identifies suitable abilities and potential
  • Contribute to an accurate resource management process to support resource planning and resource reporting according to expectations
  • Coach internal Roche project employees and support people development, provide feedback and communicate training needs in order to achieve best performance of the individual and the team
  • Develop and improves test methods, business processes, templates, sop s, standards etc. to improve the efficiency within the packaging development organization and reduce the risk of making mistakes
  • Provides clear direction to the team, sets priorities, monitors progress and provides mentorship to team members

San Francisco, California, United States of America
12/7/2017 8:36:45 AM

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