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Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

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Packaging Engineer

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Job ID SR0038766 Date posted 07/30/2019 Location Dublin, Ireland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Packaging Engineer.

As our successful Packaging Engineer, you will be responsible for the development, launch and life cycle management of primary, secondary and/or tertiary packaging components, equipment maintenance and engineering projects
You will assess, develop, design, specify, test and implement packaging projects at external and internal manufacturing and packaging sites
You will lead package trial runs, project start-ups (FATs/SATs), resolving manufacturing issues, and in packaging validation efforts. Additionally, you will be required to lead or own change control, non-conformances and CAPA activities working with Quality and Global Labelling Operations.

Key Accountabilities 
•    Execute/Lead in the introduction of new packaging components, technologies, equipment and processes by:
-    Characterizing primary, secondary and/or tertiary packaging components
-    Selection, testing and maintenance of packaging equipment 
-    Authoring and executing user requirement specifications, technical and validation protocols and reports.
-    Working with sites to qualify packaging equipment and/or new processes including ability to lead Factory Acceptance testing and site commissioning activities
-    Performing and coordinating with sites for package testing related to package qualification activities
-    Write, develop and approve packaging specifications to support all GMP packaging and labelling activities
•    Execute/Lead in identification and implementation of programs to improve the quality and/or efficiency of commercial packaging operations by:
-    Providing technical support to quality, manufacturing/packaging operations, supplier relations management and pharmaceutical sciences/process development.
-    Execute various duties to support department and/or sites, such as Change Requests, Non-conformance/CAPA, department initiatives, learning activities and various operational improvement programs
-    Troubleshooting of components and equipment issues to resolve packaging complaints, investigation and/or deviations 
•    Represents Global Packaging Engineering & Technology on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labelling Operations and other internal or external customers on new and existing products introductions to:
-    Ensure products conform to regulatory and compliance obligations (e.g. FDA, EMA, DEA, cGMP, etc.).
-    Preparation of the Packaging Sections of Regulatory submissions (Common Technical Dossiers or CMC filing).  When necessary, participate in plant-based government and corporate compliance inspections and audits
-    Provide technical form, fit, function review and approval into Takeda Artwork Management system
•    Serve as our Package Engineer to the Product Technical Teams or Site Support where necessary in ensuring continuous safe supply of commercialized product 

Education, Behavioural Competencies  
•    Bachelor’s Degree in an engineering related field required with 4 years of related experience
•    Hands-on experience and exposure to technologies applicable to the functional area.  
•    Proven capability of acquiring knowledge and applying problem-solving methodologies. 
•    Proven capability of performing process capability and statistical process control calculations.  
•    Demonstrated ability to serve as an effective cross-functional project team leader or member.  
•    Proven knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document (e.g. ISPE, PDA, ASTM, ISO, ICH, Pharmacopeias) and Regulatory CMC guidance documents applicable to the role.  
•    Experience in drafting portions of post-approval CMC technical content. Ability to author user requirement specifications, technical protocols, reports and assessments. 
•    Previous project team experience with technology transfer. 
•    Hands on experience to commercial manufacturing practices and CMO/CRO operations.  
•    Proven ability to apply problem-solving methodologies and to collaborate across functional, organizational and company boundaries.

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 SR0038766

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