Validation Specialist
takeda
Madrid, Spain
hace 4 días

Job Description

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

    Key Accountabilities

  • 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

    Functional :

  • 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.
  • Technical

  • 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.
  • Travel requirements

    Open to travel punctually

    Job ID R0019839

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