Objectives of position : Based at our Cell Therapy plant in Madrid, Validation Specialist will be responsible to lead and manage site validation activities. :
Support one or more validation disciplines (e.g., Transport, CSV, Sterilization, Cleaning, Processes) using a risk-based approach.
Participate or lead multi-disciplinary teams in the implementation of validation activities. Author and execute protocols, final reports, procedures, and other documents as necessary.
Represent Takeda during regulatory, corporate, division and third-party inspections; defend the validation program(s) to auditors and inspectors;
support regulatory submission processes as required
Author and maintain the quality system SOPs for validation. Define validation approach that is technically sound and are compliant
Develop and review of the facility Validation Master Plan (VMP) : Definition of validation methodologies and approaches
Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
Develop, review, execute studies, URS (user requirement specification), FS (functional specification), DS (design specification) and DR (design review), commissioning and validation protocols.
Assist in deviation resolution and potentials CAPA, summarize results, and author final reports. Plan and manage protocol execution, and coordinate with other departments as necessary.
Ensure the follow-up and tracking of the calibrations. Update the calibration documentation in the system
Plan calibration executions, and coordinate with other departments as necessary.
Ensure the use of risk management tools to evaluate and mitigate risks associated with equipment and facilities.
Drive efficiency, improvement and robustness in site validation systems
Be the link with Global Validation for technical information, and standards roll out.
Assess impact to validation and validation status during change management and define appropriate validation requirements and approach to maintain validated status of 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.
Act as a validation SME (subject matter expert) for validation and defend validation topics during internal / external inspections.
May give work direction to and / or mentor lower level Q&C Technicians, temporary employees, and / or contingent / contract staff.
Support investigation and change control processes when needed.
Complete mandatory training within required time frame.
Perform other duties as assigned
Education and experience
Minimum of a BS degree in Chemical, Biochemical or Mechanical engineering.
Other degrees, such as a BA or BS in biology, chemistry, math, molecular biology and / or other life science, are acceptable if the candidate has relevant experience (e.
g. education or employment in sciences or validation).
A minimum of 5- 7 years hands-on validation, engineering, and technical experience in a biopharmaceutical / pharmaceutical production environment.
Minimum of 3 years of validation experience in writing, executing, and summarizing validation protocols and testing procedures on Cleaning, Transport, Process and Sterilization.
Broad and in-depth knowledge of current validation approaches, methods, and protocols to evaluate relevant biopharmaceutical / pharmaceutical equipment, systems, facilities and utilities.
Demonstrated ability to lead troubleshooting activities and complex investigations and provide technical support services to both Operations and Quality.
Demonstrated ability to successfully plan and execute improvement projects and validation activities within a dynamic production environment.
Knowledge on Calibrations
Knowledge on equipment / systems qualification (HVAC, Cleanrooms, Gas systems, Controlled Temperature Units (CTUs) mapping, and Analytical Equipment qualifications.
Knowledge of FDA, ICH, EU, PDA, ISPE, ASME(BPE) and other global regulations and GMP guidelines associated with validation requirements
Experience with / participation in internal / external audits
Experience with Microsoft Office Word, Excel and Sharepoint
Experience with computerized Compliance (Trackwise), Calibration, and PM enterprise systems strongly desired
Skills and Competencies
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.
Able to handle multiple task / priorities and the ability to work under specific time constraints are required.
Experience with protocol development and execution, deviation identification and resolution, and summary / final report authoring.
Experience performing statistical analysis of validation test results.
Sound industry knowledge and proficiency working in a project environment.
Proficient in MS Office suite
Fluent Spanish and English (B2), knowledge of other languages will be an asset.
Behavioural / Interpersonal
Communicate effectively at all levels in verbal and written form, including technical / business writing.
Ability to work autonomously with little to no supervision
Flexibility is important and responsibilities may change, or other duties may arise for this position.
Open to travel punctually
Job ID R0019839