Computer System Validation Lead / Computer System Validation Leadess

NNIT Switzerland AG - July 7, 2025

Job Title: Computer System Validation (CSV) Lead

The Computer System Validation (CSV) Lead plays a crucial role in ensuring compliance with regulatory requirements through the validation of computer systems in the pharmaceutical industry. In this position, you will be responsible for planning, coordinating, and executing validation activities for software and computerized systems used in drug manufacturing, laboratory operations, and quality management.

Key Responsibilities:

  • Develop and implement validation strategies in accordance with regulatory guidelines (e.g., FDA, EMA, GxP).
  • Create and maintain comprehensive validation documentation, including Validation Master Plans, User Requirements Specifications, Risk Assessments, Protocols, and more.
  • Lead validation activities throughout the IQ/OQ/PQ phases.
  • Conduct risk assessments and impact analyses for various validation projects.
  • Manage project timelines, resources, and budgets effectively.
  • Communicate project status and any issues to stakeholders.
  • Participate in audits and inspections to ensure compliance.
  • Develop and conduct CSV training sessions for team members.

Requirements:

  • University degree or equivalent in Business Administration, Information Technology, or Technical Engineering.
  • At least 5-8 years of professional experience in IT Computer System Validation (CSV) and IT Quality Management.
  • Relevant project/service IT Management experience with a strong understanding of IT standards.
  • Experience in IT environments within the healthcare industry (GxP, CSV), particularly in manufacturing, is a significant advantage.
  • A team player with a high degree of assertiveness and excellent communication skills.
  • Fluency in English and German is required; knowledge of additional languages is a plus.

Offering:

  • Provide consultancy services for international clients in an intriguing and expanding market with strategically important projects.
  • Work in a professional consultancy environment within a highly motivated team.
  • Have ownership of shaping and defining new products within our service portfolio.
  • Enjoy promising opportunities for personal development within a growing company, including the potential to lead a team or business unit.

Benefits:

  • Paid internet at home.
  • Public transport expenses covered.

Onsite presence in Basel required at 100%.
Apply online using the form below. Note that only applications matching the job profile will be considered.

Location : Basel
Country : Switzerland

Application Form

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