Skip to main content

Search Our Jobs

Search with LinkedIn Profile

Sr Process Validation Engineer

Social Circle, Georgia


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.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Back to Job Navigation (Overview)


What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

Back to Job Navigation (Success)


  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

Back to Job Navigation (Rewards)

Sr Process Validation Engineer

Apply Now
Job ID SR0045131 Date posted 12/16/2019 Location Social Circle, Georgia

Effectively contribute to manufacturing support by leading the execution of process validations necessary for the implementation of process changes including new product introduction and improvements of existing commercial processes.  This role will assist in the execution of the Site’s process validation program by providing in-depth scientific understanding of large-scale protein purification.

With minimal oversight, an employee in this role will:

  • Review and assess process changes for impact to current validated state
  • Analyze process validation deviations and document analysis and justifications/conclusions
  • Review and assess changes to process documentation
  • Define Site process validation strategy from a protein biochemistry perspective
  • Appliy thorough understanding of cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
  • Perform a variety of projects/studies in areas that may include Product/Process, sterilization, as well as projects/studies to support manufacturing.
  • Handle projects that are more complex and broad in scope, such projects require team leadership, task prioritization, and management of budget and/or time constraints. Must demonstrate competent and effective planning, coordination, and organizational skills.
  • Author and review protocols, reports, Change Controls, Regulatory submission content.

Conduct Studies and Execute protocols


  • Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
  • Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.
  • Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to technical operations (product development, design and safety) to ensure compliance in all development, data collection and reporting activities.
  • Recommend appropriate designs, techniques and processes for a specified sequence of tasks where needed. Contribute to technical feasibility analysis of complex research and design concepts
  • Monitor budgets and/or activity schedules of limited scope.


  • Minimum of a Bachelor's degree, preferably in Engineering, Molecular Biology, Chemistry or Biochemistry plus a minimum of 5 years pharmaceutical industry experience required. Advanced degree (MS and/or PhD) in similar disciplines plus 0 to 5 years industry experience preferred.
  • Education in the use of statistics for data analysis; the ideal candidate will have experience using Minitab, SIMCA or similar software
  • Direct experience in bioprocess; the ideal candidate will have experience in protein processing and purification

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.

Job ID SR0045131

Apply Now Email Me

Explore the Area

Check out where you could be
working if you apply.

View Map