Computer Systems Validation (CSV) Specialist | Pharma (Hybrid)

We are looking for a Computer Systems Validation (CSV) Specialist to play a key role in ensuring compliance with regulatory requirements and internal standards by leading validation efforts throughout the system lifecycle. This position requires strong collaboration across cross-functional teams and a solid understanding of risk-based validation methodologies.

TASKS & RESPONSIBILITIES 🚀:

• Ensure that all validation activities are properly planned and executed in accordance with validation strategies, GxP requirements, and applicable BI SOPs prior to system go-live.
• Maintain the system’s validated state throughout its lifecycle.
• Collaborate closely with Quality Assurance (QA) on compliance-related topics.
• Coordinate with System Owners, Process Owners, Business Process Owners, System Leads, Developers and other stakeholders.
• Ensure that all system-specific SOPs and System Lifecycle (SLC) documentation are in place before system operation.
• Oversee testing activities, including review and approval of executed test cases.
• Provide audit support and maintain up-to-date system documentation and presentations.
• Manage and resolve System discrepancies in collaboration with global system roles.
• Drive continuous improvement by optimizing and simplifying validation processes using risk-based approaches.

SKILLS 🤹:

• Degree in Business Administration, Computer Science or comparable professional experience.
• Proven experience in validation within a GxP-regulated environment, preferably in an IT area.
• Strong knowledge of GAMP5 (v2) principles and their practical application.
• Ability to quickly learn and manage lifecycle documentation (e.g., Validation Plan, URS, Functional Specifications, Risk Assessments, Test Reports, AAP, etc.).
• Experience in developing and delivering training on KBs and SOPs aligned with the Validation Plan and AAP.
• Familiarity with ITIL v4 is considered an advantage.
• Excellent written and spoken English.
• Proven ability to work effectively in a virtual, international, and multicultural environment.
• Strong organizational, analytical, and problem-solving skills, with a results-driven mindset.
• Excellent communication, collaboration, and stakeholder management skills.

SCHEDULE 🕘:

• 08/09h -17/18h from Monday to Friday (flexible)

• 4 days by remote & 1 day on-site

CONDITIONS 🌱:

• Salary package based on your profile. We will discuss it on our first call.

• Permanent Contract

• Ticket restaurant included in-office hours

• Flexible Retribution Program (Urban Sports Club)

• Learning & Development

• Friend Referral Program

Our goal is that you are well in every way!