Posted to MedZilla on 11/14/2019

Takeda Pharmaceuticals

US-GA, Process Engineer, Packaging SR0042525-MZ


The position will be a team member of the Process Engineering group. Process Engineering is responsible to ensure that the manufacturing equipment/systems used in the production, storage, testing and distribution of products are fit for purpose in accordance with company standards and industry regulatory requirements.

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. The engineer will assess, develop, design, specify, test and implement packaging projects. They also review and improve existing packaging designs. They work with internal resources and packaging suppliers to achieve functional packaging goals.

The engineer 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 Labeling Operations. This position will provide support to manufacturing system. The Engineer will implement area and system improvements through strict adherence to Standard Operating Procedures and cGMP s in a Pharmaceutical Manufacturing facility.


Key Accountabilities

  • Provide technical expertise in their area of specialization (i.e., Packaging Technology /Equipment, Package Design, Serialization, Product Security, Packaging Process Development & Optimization, etc.).
  • Equipment Owner and /or the Execution Lead, for one or more processes in their respective area of specialization, including but not limited to:
    • Packaging Equipment
    • Characterizing primary, secondary and/or tertiary packaging components
    • Selection, testing and maintenance of packaging equipment
    • Combination Product and Device Packaging
    • Packaging & Art-Work Specifications
    • Packaging Process Development and Optimization
    • New Technology Acquisition
    • New Package Introduction
    • Identification and qualification of alternate sources for packaging components
  • 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, as needed.
  • Write, develop and approve packaging specifications to support all GMP packaging and labeling activities.
  • Execute/Lead in identification and implementation of programs and/or projects 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.
    • Lead and conduct complex technical investigations
    • Author, review, approve technical documentation, including but not limited to SOPs, Validation Master Plans and Technical Reports.
    • Troubleshooting of components and equipment issues to resolve packaging complaints, investigation and/or deviations.
  • Provide technical perspective during internal and external audits, regulatory inspections and due diligence.
  • Serve as a Package Engineer to the Product Technical Teams or Site Support where necessary in ensuring continuous safe supply of commercialized product.

Education and Experience Requirements

  • Bachelor's degree in Engineering discipline required. 5+ years of related experience. Some leadership experience preferred for supervisory roles. The minimum requirement to become a packaging engineer is a bachelor s degree in engineering, packaging science, or another relevant field. Typically, employers also require previous experience in a similar role.

Key Skills, Abilities, and Competencies

  • Must have a demonstrated track record of successfully executing engineering projects, and supporting facility issues, in a FDA-regulated manufacturing environment.
  • Proven knowledge and application of cGMP requirements
  • Possess knowledge of core principles in various engineering disciplines including manufacturing (i.e. aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design.
  • Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
  • Must have the ability to effectively participate in Engineering projects and drive results.
  • Direct experience with manufacturing operations and biotechnology processes is strongly preferred.
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
  • Knowledge of programmable logic controllers, DCS, instrumentation and controls highly desirable.
  • Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
  • Must be a self-starter, detail oriented and able to work independently.
  • Must embrace working in a fast-paced, team-oriented, cross-functional environment.
  • Work independently with some to limited supervision.

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.

EEO is the Law -

EEO is the Law Supplement -

Pay Transparency Policy -

Reasonable Accommodations

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.

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.