Sr Packaging Development Engineer, Steriles

8 - 10 years experience  •  Business Services

Salary depends on experience
Posted on 09/22/17
San Francisco, CA
8 - 10 years experience
Business Services
Salary depends on experience
Posted on 09/22/17

TheSenior Packaging Engineer in this position manages and/or executes complexpackaging projects with multiple stakeholder interfaces. They identify businessneeds, defines goals and develops project execution plans. They calculate thebusiness case, asks for endorsement and executes the project. They organize theproject in collaboration with the subject matter expert-departments. Theydefine responsibilities within the scope of project organization, monitors theprogress of the project and ensures compliance with costs, schedule and qualityconstraints. They undertake proactive measures to achieve project goals in theevent of deviations from the project plan, exercises judgment in selecting methods,techniques and evaluation criteria for obtaining results and works on complexissues where analysis of situations and data requires in-depth knowledge andunderstanding of the organization.

They establish priorities, timelines and deliverables, providesthe necessary leadership, technical expertise and tactical execution to ensurepackaging life-cycle efforts on a global level (design, development, testing,qualification and maintenance of global secondary and tertiary packagingcomponents and processes) to meet business, regulatory and technicalrequirements. 

TheSenior Packaging Engineer in this position works under limited direction andestablishes his/her own work priorities and timelines. They leverage acentralized approach to promote compatibility and standardization between anetwork of in house and contract packaging facilities. The success of thisfunction requires effective collaborations with Early and Late StagePharmaceutical Development, Contract Manufacturing, Marketing, Supply Chain,Manufacturing, Packaging Operations, Regulatory, etc., and by providingtechnical expertise, project leadership and on-going support to resolve issuesand introduce new technologies and processes.

Scopeof this responsibility includes the development and qualification of globalpackaging solutions. Projects in the areas of clinical packaging, productlaunches and marketed products can be assigned.

Primary Responsibilities/Accountabilities:

  • Developand qualify global secondary and tertiary packaging solutions for sterileproducts
  • Qualificationof global packaging solutions in line with the current valid requirements (e.g.Development of test protocols and reports, execute IQ, OQ, and PQ etc.)
  • Maintenanceof global packaging solutions (e.g. maintain global specifications, supportchange control records, provide impact assessments, execute requalificationetc.)
  • Evaluateand develop new materials and/or alternate packaging materials, packagingsolutions or packaging systems based on product, regulatory, business ortechnical requirements
  • Ensurecompliance with international regulations (GMP, SHE, pharmacopoeias,authorities, requirements) and adherence to relevant Roche Quality Directives,Procedures, Guidelines, GSP’s
  • Supportthe Contract Management Organization (CMO organization with the evaluation andselection of new CMO’s and provide input about the packaging relevant technicalcapabilities of existing CMO’s
  • Supportexternal quality and global procurement with the selection and qualification ofglobally relevant suppliers
  • Managepackaging development project/topics or packaging development sub-projects inglobal team. Drive the packaging topics to meet predefined timelines. Drive theprocess to establish and agree on packaging requirements and meet agreed technicalrequirements, agreed timelines and financialbudget contains accordingagreement
  • Worksautonomously on complex tasks or several parallel tasks and projects. Setspriorities and fulfills deadlines. Majority of projects have strategicrelevance for the organization
  • Supportcontract-manufacturing sites (CMO’s) with regard to development, qualificationand implementation of secondary and tertiary packaging solutions as well aspackaging & transport processes for sterile products
  • Artworkproofing and approval for CMO’s
  • Successfulcollaboration with internal and external stakeholders (Global packagingdevelopment non-steriles, DTech, CMO, Procurement, Device development, primarypackaging development, QA, Small molecules sites, Biologics sites, etc.)
  • Providepackaging technical support on global technical development teams (TDT), technicalproduct teams (TPT), product technical teams (PTT) and global devicedevelopment teams for clinical packaging, commercial product launches and postlaunch maintenance for global packaging solutions
  • Facilitateand foster exchange between different Roche packaging sites related topackaging topics like future trends, new technologies, process improvementsetc. Represent the packaging development organization as a prime contact oninitiatives, projects and as a subject matter expert
  • Bringand develop packaging expertise into the organization and function as a keycommunication interface between Sales/Marketing, Manufacturing, ContractManufacturing, Quality, R&D and suppliers in the development and executionof technical packaging initiatives. Interacts with senior internal and externalleaders on packaging strategies, trends, investment needs and explains theimpact for the organization
  • Communicateeffectively and in a timely manner. Regularly communicate project status,critical issues and events of the project to the project leader, stakeholdersand line function. Ensure that management is informed ahead of time when goalsare not fully achieved
  • Activeand constructive contribution to the gPKD Team. Support team spirit, teamalignment, share responsibility, sharerisks in the team beyond the functionand overall. Develop knowledge for the organization and share the gained knowhow with the team members. Focuses and motivates team members toward a commongoal and identifies suitable abilities and potential
  • Contributeto an accurate resource management process to support resource planning andresource reporting according to expectations
  • Coachinternal Roche project employees and support people development, providefeedback and communicate training needs in order to achieve best performance ofthe individual and the team
  • Developand improves test methods, business processes, templates, sop’s, standards improve the efficiency within the packaging development organization andreduce the risk of making mistakes
  • Providesclear direction to the team, sets priorities, monitors progress and providesmentorship to team members

Who You Are

  • Bachelordegree, preferably with an engineeringdegree in packaging, materials science,or a related field
  • 8years experience in secondary and tertiary packaging development or packagingfor clinical or commercial drug products or combination products
  • Excellentcollaborative and communication skills. Communicates in a well-structuredmanner and concentrates on key topics. Presents in an entertaining manner anddemonstrates good negotiation skills
  • Open-minded,self-driven individual motivated to drive self-initiated continuous improvementand innovation efforts
  • Languages,knowledge of German an asset, English essential
  • Projectmanagement and team management experience
  • Experiencein other disciplines (e.g. consumer packaging, distribution, product design,etc.) and other areas of business (e.g. manufacturing, supply chain, quality,etc.)
  • Statisticalknowledge including Design of Experiments (DOE) and Quality by Design (QbD),statistical software such as Minitab
  • Knowledgeof testing methodologies and test standards including, shock, drop andvibration testing, peel force testing, barrier analysis, Container ClosureIntegrity (CCI)/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTMstandards for packaging design and validation
  • Knowledgeof sterile barrier system development for terminally sterilized medicaldevices, suitable for the use in sterilization processes
  • Knowledgeof packaging equipment, related to sterile packaging activities (e.g. vials, pre-filledsyringe, devices, aseptic form/fill/seal) and printing systems
  • Knowledgeon equipment qualification/validation (IQ, OQ, PQ, PV) and development ofqualification protocols / reports for packaging and shipping qualificationactivities
  • Developand maintain packaging specifications
  • Knowledgeregarding design control, documentation, risk management and processes
  • Workingknowledge of computer systems including TOPS, CAD or Solidworks, and Microsofttools including MS project, and Adobe
  •  10-20% travelrequired

Job ID: 2565307605

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