Principal Engineer - Packaging
Lexington, Massachusetts, Dublin, Ireland
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Principal Engineer - PackagingApply Now
- The Principal Engineer provides leadership, direction and advanced technical expertise to the Packaging Engineering OESSM organization 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, launch and life cycle management of primary and/or, secondary and/or, tertiary packaging components and/or equipment maintenance and engineering projects.
- 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.
- The candidate will lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations and is expected to provide coaching and guidance to junior members of the team
- 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),
- First time right documents,
- Cost of goods productivity improvement
- 100 % filing submissions on time and correct,
- 100 % Regulatory responses on time and correct, etc
- 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 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 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, such as, 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 Regulatory, Marketing, Product Strategy Leaders, Global Labeling 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.
- Ten or more years of experience leading highly effective technical teams, developing people and technical capabilities.
- Experience in 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
- Solid organization, problem solving, project-management, decision-making, judgment and team-oriented skills are essential.
- Demonstrated ability to simultaneously manage multiple projects of variable complexity.
- Strong technical, interpersonal, communication and leadership skills.
- Travel of up to 25% may be required
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.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Job ID SR0036749