Validation Technician (CSV) | Pharma (100% remote)

Ambit Iberia; Barcelona; A distancia; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking a Validation Technician to join their global, multicultural team. This permanent position offers a fully remote working environment, focusing on managing validation documentation, supporting the implementation of new systems, and ensuring compliance with industry standards. Ideal candidates will possess a relevant degree, extensive experience in validation, and strong communication skills.

Formación

• Over 4 years of experience in the sector.
• Experience in conducting change controls to ensure compliance with 21 CFR Part 11 and EU GMP Annex 11.

Responsabilidades

• Generation of validation documentation such as Validation Plan/Report, Risk Analysis, Qualification Protocols.
• Support in the execution of qualification protocols.
• Plan and manage projects according to client requirements.

Conocimientos

Computerized systems validation

Facility Management

Engineering

GxP knowledge

Data Integrity

Strong communication skills

Fluency in English

Educación

University degree with postgraduate or Master's studies (Chemical Engineering, Industrial Engineering, Chemistry, Biology, Biotechnology)

Herramientas

Microsoft Office 365

Descripción del empleo

Would you like to work in a global, multicultural and multilingual team? We are looking for a "Validation Technician" who will offer service to a pharmaceutical company. Managing Validation Documentation and support the implementation of new functionalities/systems.

Responsibilities :

• Generation of validation documentation (Validation Plan/Report, Risk Analysis, Qualification Protocols: e.g. OQ, PQ).
• Support in the execution of qualification protocols.
• Maintenance of validation status: execution (e.g. Periodic Reviews).
• Plan and manage projects, according to client requirements and applicable legal regulations, in order to achieve the company’s strategic objectives.
• Address queries to technicians and create validation documentation for the projects you lead.

SKILLS:

• University degree with postgraduate or Master's studies (Chemical Engineering, Industrial Engineering, Chemistry, Biology, Biotechnology).
• Over 4 years of experience in the sector.
• Experience in computerized systems validation, Facility Management, engineering and Security.
• Knowledge of GxP (GMP, GDP) in the pharmaceutical sector.
• Experience in conducting change controls to ensure compliance with 21 CFR Part 11 and EU GMP Annex 11.
• Knowledge of Data Integrity and GAMP. **
• Advanced knowledge and use of office software: Microsoft Office 365
• Strong communication skills.
• Fluent in English.

SCHEDULE :

• From Monday to Friday: 08 am to 17 pm / 09 am to 18 pm (flexible)
• 100% remote position
• Permanent Contract

Our goal is that you are well in every way!