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Sr QA Validation Associate

Social Circle, Georgia

Overview

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.

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Success

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

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Opportunity

  • 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 2021.

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

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Sr QA Validation Associate

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Job ID R0030085 Date posted 04/20/2021 Location Social Circle, Georgia

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Job Description

This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for compliance in the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines:

  • Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems
  • Computerized systems validation
  • Facilities, Utilities, and Equipment (FUE) qualification
  • Electronic Batch Management (EBM)
  • Cleaning validation
  • Sterilization validation
  • Materials qualification
  • QC Laboratory
  • Data Integrity Assessment

Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Individual must work on moderate to complex assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.

Job Function and Description

  • Independently review commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies.
  • Provides compliance guidance to Engineering for all related commissioning, qualification and validation activities.
  • Collaboratively conducts risk and impact assessments.
  • Supports development and review of standard operating procedures (SOP) and validation assessments.
  • Interfaces with customers on technical issues, project timeline, and validation support.
  • Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
  • Calculation and interpretation of data for commissioning, qualification and/or validation studies.
  • Participates in audits and regulatory agency inspections as a representative of the Quality Validation team, as required.
  • Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
  • Provides support for operations and communicates with Program Managers.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.
  • Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
  • Leads several small projects with complex features.
  • Typically requires bachelor's degree in science, engineering or other related technical field. 5+ years of related experience.
  • A minimum of 5 years of relevant experience in a GMP regulated environment.
  • At least 4 years of commissioning, qualification and validation (CQV) desired.
  • Validation and/or system experience in the following applicable areas:
  • Sterilization and aseptic processing validation.
  • Cleaning validation of manufacturing equipment.
  • Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
  • Protein purification from mammalian plasma and/or blood.
  • Strong knowledge and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
  • Ability to effectively lead validation projects, coordinate contractors, and drive results.
  • Direct experience with manufacturing operations and biotechnology processes is strongly desired.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0030085
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