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Senior Process Validation Engineer II

Lexington, Massachusetts


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Senior Process Validation Engineer II

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Job ID SR0054655 Date posted 10/15/2020 Location Lexington, Massachusetts

Primary Duties

The individual will be expected to provide process validation support for Takeda biologics manufacturing operations located in Lexington and Cambridge MA, USA.  The process validation activities related to the Lexington & Cambridge manufacturing site include, but are not limited to, the following areas:

  • Development of process validation protocols and other documentation for cell culture and purification processes.
  • Execution of process validation studies, as well as data analysis and compilation of data and results into summary and final reports.
  • Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
  • Own process validation related quality systems (CAPA, Change Control) and use project management skills to coordinate those project teams and drive results.
  • Participate in regulatory inspections.
  • Represent process validation team on project core teams and participate in strategy discussions on behalf of process validation in collaboration with PV strategy team and aligned with global PV and regulatory requirements.
  • Support and interface with global PPQ community of practice where needed to ensure alignment and consistency with global practices


80% of Time:

Write, execute, analyze results and summarize process validation activities in the following areas:

  • Tech transfer (new product introduction)
  • Change management
  • Continuous lifecycle management

Develop and assess the following Quality System elements for process Validation:

  • Quality Risk Management program
  • CAPAs
  • Change Controls
  • Deviations
  • GMP Investigations

Participate and contribute in design, development, validation strategy, and routine GMP activities:  

  • Provide technical input to strategy/philosophy for validation activities
  • Represent process validation during tech transfer activities as required.
  • Represent process validation during site GMP activities and participate on cross-functional teams
  • Own process validation Quality Systems, as required, and manage project through to closure per timelines

15% of Time

  • Identify opportunities for continuous improvements, participate in the deployment of best practices, represent process validation at Lexington Site Work System meetings and support/maintain the process validation communications board and community of practice. 

5% of Time

  • Participate in regulatory agency inspections for Process Validation.
  • Train other Takeda staff on validation protocols.

Education and Experience Requirements


Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of 8 years relevant experience or Master’s in related field with a minimum of 5 years relevant experience.

Key Skills, Abilities, and Competencies

Qualified candidates will have:

  • Relevant experience with industry process validation requirements and expectations
  • Working knowledge of the science and technology for the major unit operations associated with manufacturing operations.
  • Experience with troubleshooting / problem solving and risk assessment / mitigation. 
  • Good written and verbal communication skills. 
  • Strong team member with demonstrated ability to work collaboratively with others.
  • Ability to work independently in a fast paced environment and manage multiple projects and priorities.

Complexity and Problem Solving

The candidate will:

  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Must have the ability to analyze data, quantify risks, and identify gaps independently.
  • Must have the ability to propose solutions to problems and escalate issues with proposed solutions to management as necessary. 

Internal and External Contacts

  • The person in this role will be instrumental in working with other members of the Quality, Manufacturing and Engineering organizations to develop and execute process validation studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals.
  • Other departments this person will work closely with include:  Process Development, Manufacturing Sciences, and Technology, Manufacturing, Regulatory Affairs, Quality Control, Quality Assurance, Engineering, Facilities.

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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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.

Job ID SR0054655

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