Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Packaging Engineer in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- The Principal Engineer provides leadership, direction and advanced technical expertise to the Packaging Engineering Oncology, Small Molecule Op U in their respective area or areas of specialization (i.e., Packaging Technology, Package Design, Packaging Engineering, Serialization, Product Security, Packaging Process Development & Optimization, etc.).
- The incumbent may be the execution lead and may act as the Process Owner for one or more processes in their respective area of specialization. This role is also involved in the development (supporting development s execution of registration batches) in combination with Manufacturing Science, launch life cycle management and continuous improvement of primary and/or, secondary and/or, tertiary packaging components and/or equipment maintenance and engineering projects based on fit-for-use criteria defined by packaging site leads.
- The candidate will lead in the development, design, specification, testing, implementation and commercial support of packaging activities at external and/or internal manufacturing and packaging sites for commercial product. We support Manufacturing Sciences development of new product packaging designs ensuring our collaboration on feasibility, manage clean technical transfers once product is launched
- The candidate will lead or own change control, non-conformance and CAPA activities working with Quality and Global Labeling Operations and is expected to provide coaching and guidance to junior members of the team. Lead technical transfer activities from Manufacturing Sciences into Commercial processes
- Provide technical expertise in their area of specialization (i.e., Packaging Technology, Package Design, Serialization, Product Security, Packaging Process Development & Optimization, etc.).
- May be the Process Owner and /or the Execution Lead, for one or more processes in their respective area of specialization, including but not limited to:
- New Technology Acquisition
- Packaging Equipment
- New Package Introduction
- Combination Product and Device Packaging
- Packaging & Art-Work Specifications
- Packaging Process Development and Optimization
- Identification and qualification of alternate sources for packaging components
- Responsibility for Process Ownership requires the incumbent to ensure a clear definition of the process start to finish is understood; quality documentation of the process is maintained (i.e., work process map, process summary, training materials, SOPs, etc.); establish process goals and targets; monitor process performance; guide, influence and train others to ensure the process is followed consistently, and seeks to continuously improve the process.
- Will develop and maintain the technology capability strategy (for their specific area or areas of expertise), which defines the capability we need to deliver our services and the actions we need to take to maintain and continuously improve that capability.
- Lead, manage 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, Validation Master Plan, Regulatory Filing Support Documentations, etc),
- Documentation which are right first time
- Cost of goods productivity improvement
- 100 % on time and accurate filing submissions,
- 100 % on time and accurate filing of regulatory responses
- Will work with external contract packaging network and internal packaging sites to create or enhance packaging capabilities to deliver the needed capacity, quality and quantity of packaged goods required by our patients.
- Will partner with sites to ensure quality in product packaging and drive towards the elimination of customer complaints relating to packaging.
- Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.
- Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.
- Promote continuous improvement in efficiency, quality, and safety through technical development, education and training.
- Lead and conduct complex technical investigations
- Author, review, approve the relevant regulatory and technical documentation, including but not limited to CMC, SOPs, Validation Master Plans and Technical Reports.
- Provide technical perspective during internal and external audits, regulatory inspections and due diligence.
- Recruit and manage external resources and appropriate budgets for Consultants and Contractors, as needed to deliver projects.
- Interface directly with all Customers and ensure highest level of Customer satisfaction.
- To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations.
- Represents Packaging Engineering OESSM on development and commercialization teams as appropriate by interfacing with Manufacturing Sciences, Pharm. Sciences, Strategy and Business Excellence, Regulatory, Marketing, Product Strategy Leaders, Global Labelling Operations and other internal or external customers on new and existing products introductions
- Serve as a Package Engineer to the Product Technical Teams or Site Support where necessary in ensuring continuous safe supply of commercialized product (25%)
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Normally requires an advanced degree in a scientific/technical discipline with 8 years related experience OR a BS with 12 years related experience. Applies expert knowledge of scientific/technical principles & concepts in managing technical programs such as:
- Technology acquisition
- Equipment installation & qualification
- Process development, scale-up and optimization
- Package design development for Oral Solid Dose, Aseptic and Device Delivery systems including primary, secondary and tertiary packaging
- Technology transfer
- Qualification of packaging components from alternate sources
- Strong technical, interpersonal, communication and leadership skills.
- Solid organization, problem solving, project-management, decision-making, judgment and team-oriented skills are essential.
- Experience in leading highly effective technical teams, developing people and technical capabilities.
- Experience in execution of global product launches and the associated CMC regulatory requirements.
- Advanced knowledge of cGMP/GLP regulations
- ICH, FDA CMC Guidance Documents and DEA Regulations is preferred. JP, SFDA, etc. is a PLUS
- Demonstrated ability to simultaneously manage multiple projects of varying complexities.
- Travel of up to 25% may be required
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.