Validation Technician

Grifols Sa; Málaga; Híbrido; EUR 45.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Descripción de la vacante

Grifols is seeking an IT Validation Technician to execute validation methodologies and oversee teams in validation activities. You will ensure GxP compliance for IT systems and support regulatory inspections in an international setting.

The role requires a Life Sciences degree, 3+ years in a regulated pharma environment, and strong project management and communication skills. A hybrid work arrangement is offered in Málaga and surroundings.

Formación

• Bachelor’s degree in Life Sciences.
• Minimum of 3 years of proven experience in a regulated pharmaceutical environment with GxP.
• Strong understanding of project management methodologies, tools and best practices.
• Knowledge of regulatory requirements and GxP standards relevant to computerized systems.
• Experience supporting regulatory inspections and audit responses.
• Excellent attention to detail with ability to manage multiple priorities.
• Ability to work independently and collaboratively in cross-functional, international teams.
• Excellent organizational, communication, and problem-solving skills.
• Advanced in English, with ability to work effectively in an international environment.

Responsabilidades

• Relationship Management, Planning, and Strategic Alignment with business and IT partners.
• Proactively identifies project risks and issues, and defines escalation and mitigation steps.
• Regularly communicates deliverables status to Manager, Project Manager, and project team.
• Assists in estimating project cost and time requirements, assessing capabilities.
• Creates, reviews, updates CSV documentation per IT Validation methodologies.
• Ensures compliance of GxP IT systems with regulatory and data integrity requirements.
• Contributes to development and evolution of IT policies, procedures, and tools.
• Shares IT best practices with partners and mentors junior staff.
• Supports audits of validated systems with necessary documentation.

Conocimientos

Project management

Regulatory compliance

GxP knowledge

Documentation skills

Communication skills

Educación

Bachelor’s degree in Life Sciences

Descripción del empleo

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.

Mission

The IT Validation Technician actively contributes to the execution of the defined validation methodologies which comply with company standards and regulatory requirements. This role also oversees teams and validation resources engaged in validation activities.

What your responsibilities will be

• Relationship Management, Planning, and Strategic Alignment
  
  
  
  • Builds effective and trusting working relationships with all business and IT partners in areas of responsibility and collaboration.
  
  
  • Continuously improves knowledge of business processes, industry trends, and IT systems to better communicate IT capabilities and support IT solutions development.
  
  
  
  
• Project Delivery and Management
  
  
  
  • Proactively identifies project risks and issues, helps determine necessary escalation, mitigation, and resolution steps.
  
  
  • Regularly communicates deliverables status, concerns, and issues to direct Manager, the Project Manager, and the project team.
  
  
  • Participates in estimating project cost and time requirements, assessing capabilities and support/resource requirements in area of responsibility.
  
  
  • Creates, reviews, updates, and may approve CSV documentation for changes and projects as assigned in accordance with IT Methodology: Validation Plans, Risk Analysis, Validation Test Designs and Reports.
  
  
  • Assures the compliance of the GxP relevant IT systems with the regulatory and data integrity requirements.
  
  
  
  
• IT Operational Support
  
  
  
  • Ensures IT quality and regulatory compliance through adherence to quality control standards in all activities.
  
  
  • Contributes to the development, documentation, and evolution of IT policies, procedures, and tools to align with business and IT strategies and ensure sustainability of services
  
  
  • Regularly communicates individual task status, open issues, and challenges to impacted stakeholders and/or direct manager.
  
  
  
  
• Knowledge Sharing and Consulting
  
  
  
  • Participates in the education of partners in industry and IT best practices in areas of responsibility and expertise.
  
  
  • Mentors peers and junior level staff with both challenging and routine assignments by sharing knowledge and experience.
  
  
  • Shares developing expertise of industry and IT best practices with peers and business partners.
  
  
  • May participate in the development of ongoing training for IT staff in specific areas of knowledge.
  
  
  • Provides support in the event of internal and external audits of validated systems, preparing supporting documentation as required.
  
  
  
  
• Participates in the continuous enhancement of systems, technologies, methodologies, and services to improve IT effectiveness and system performance.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• Bachelor’s degree in Life Sciences (Biology, Pharmacy, Biotechnology, Chemical or a related discipline).
• Minimum of 3 years of proven experience working within a regulated pharmaceutical environment, including GxP compliance.
• Solid understanding of project management methodologies, tools, and best practices.
• Knowledge of regulatory requirements and GxP standards applicable to computerized systems.
• Experience supporting regulatory inspections and audit responses.
• Strong attention to detail with the ability to manage multiple priorities simultaneously.
• Ability to work both independently and collaboratively in cross-functional and international teams.
• Excellent organizational, communication, and problem-solving skills.
• Advanced in English, with the ability to work effectively in an international environment.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexibility for U Program: Hybrid Model.

Benefits package

Contract of Employment:Permanent position.