CSV VALIDATION SPECIALIST (HYBRID) Lisboa

CSV VALIDATION SPECIALIST (HYBRID)
Lisboa
Lisboa, Lisboa, Portugal

Portuguese company hires for hybrid work

Working Model: Hybrid

Location: Lisbon

Language Requirements: Fluent Portuguese / English B2

Seniority: 3 - 5 years

Sector: Pharmaceutical / Healthcare

Instructions: Please send your CVs in English and make sure to include all skills and experience that match the requirements of the opportunity. This will significantly increase your chances of success.

As a CSV Validation Specialist, you will play a key role in developing and executing validation strategies for Computer System Validation (CSV) projects, ensuring compliance with industry standards and company policies. Working collaboratively with your team, you will create and maintain comprehensive validation documentation — including validation plans, protocols, and reports — aligned with SOP-1705 and other applicable standard operating procedures (SOPs) in the pharmaceutical industry.

You will work closely with
- functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure validation activities meet project timelines and technical requirements. Throughout the validation lifecycle, you’ll ensure strict adherence to regulatory standards (e. g. , FDA, ISO) and internal compliance guidelines. Additionally, you will provide guidance and training to team members on CSV best practices and procedural compliance. /

Your Profile

Must Have / Must be clearly listed on your CV

• Bachelor’s or Master’s degree in a related field (e. g. , Computer Science, Information Technology, Engineering).
• Minimum of 3–5 years of experience in Computer System Validation (CSV), ideally in a regulated environment.
• Solid understanding of the Software Development Life Cycle (SDLC) and its integration into validation processes.
• Strong analytical and
  - solving skills, with the ability to identify issues and implement effective corrective actions.
• Proven background in IT validation, preferably within the pharmaceutical or healthcare industry.
  
  

• Familiarity with industry standards and regulations relevant to CSV (e. g. , Gx
  P, 21 CFR Part 11).
• Experience using validation tools and methodologies.
• Ability to produce detailed, compliant documentation (SOPs, validation protocols, and reports).
• More than 5 years of overall experience in the field.