Senior Validation Engineer応募後で応募 求人ID R0060356 掲載日 03/10/2022 Location:Lessines, Belgium
About the role:
The Senior Validation Engineer ensures qualification/validation activities are performed linked to his/her part of the Purification business; and contributes to digital transformation, continuous improvement, standardization and simplification of processes. Act as a technical validation expert, the validation engineer prepares, implements and coordinates the validation documentation required to assure the proper development of a project and support regulatory submissions. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon; and supports the Validation Leader as experienced validation expert and potential delegate.
How you will contribute:
- Prepare and implement the validation documentation required to assure the proper development of a project in line with Takeda’s procedures.
- Act as a validation representative for projects :
- Define and implement all validation activities related to the project.
- Develop the Validation Plans: define validation methodology and approach.
- Participate in the planning session and core team project meetings.
- Provide validation expertise for the development of the project.
- Conduct the validation risk assessment related to the project and prepare related documentation.
- Participate in URS definition, review the FS and DS
- Prepare the Design Review / Design Qualification
- Review or prepare commissioning protocols and reports (as appropriate) to ensure leveraging into qualification
- Prepare and implement IQ, OQ & PQ protocols.
- Assure requirements traceability throughout the whole project validation file (from URS to PQ).
- Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)
- Analyze, interpret, document and report the testing results.
- Coordinates the validation activities of the projects assigned to him/her. Update the validation documentation system.
- Assure feedback of status and issues to the Validation Leader.
- Prepare 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
- Contributing to digital transformation, continuous improvement and International standardization for topics related to his/her part of the business, with the support of validation leader if needed
What you bring to Takeda:
- BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
- 3 years as a Validation Engineer with efficient technical skills.
- 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
- Digital awareness
- Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
- Knowledge of the manufacturing processes
- 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.
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.