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About the role :
The CSV Validation Engineer is responsible to perform Computerized System Validation activities according to applicable regulatory requirements.
How you will contribute :
Ensure qualification / validation activities are performed linked to his / her part of the business (Purification, Finishing, Packing or CSV)
Prepare validation documentation and protocols
Act as a technical validation expert, prepares, implements and coordinates the validation documentation required to assure the proper development of a project and support regulatory submissions.
Prepare / lead the Periodic Review for Critical Systems.
Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
Support contractors or junior engineers as well as provide day to day guidance for the execution of Validation activities.
Defend validation topics related to his / her projects during Regulatory Inspection and prepare validation parts of the submission file
Validate new digitalization tools
What you bring to Takeda :
Master’s degree in industrial or automation engineering, or other job related discipline
At least 2 years as a Validation Engineer with efficient technical skills
Knowledge of a pharmaceutical industry or industrial IT or Automation
Project management experience
Good communication skills, fluent in English (written and spoken)
Familiar with Quality Management and GxP Regulations
Has the ability to prioritize multiple tasks and work on multiple projects simultaneously
Knowledge of Validation Methodologies
Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP, GAMP5 methodology and data integrity requirements
Knowledge of the manufacturing processes and production automated
Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
Experience with Continuous Improvement initiatives
PC skills and be competent in basic Microsoft tools
More about us :
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine :
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status .
At Takeda, we embrace diversity as a whole.