Computer System Validation Specialist

Epista Life Science is growing and they are looking to add computer software validation (CSV) specialists to their team!

About the job;

Epista’s team of experts have an abundance of experience working with CSV and with the updated guidelines, more and more Life Science companies will need help applying them to their businesses. That is where your expertise come in. Epista’s team is growing and needs more consultants with CSV experience to help their customers stay in compliance.

Epista are expanding their service capabilities, so are looking to add CSV consultants to the team to help guide customers through times of change.

Depending on your expertise and interest, you may work with:

Computerized System Implementation – Take the role as Validation Lead in implementation projects

Risk Based Approach – Lead with a risk-based validation strategy maximising the use of vendor documentation where appropriate

Validation Advisory – Act as SME for advisory within CSV and with a future focus on CSA

Cloud Validation – Set Cloud Control Strategies and Cloud Vendor Management.

Your Qualifications;

  • At least 5 years of experience of Compliance in the Life Science industry
  • High level of expertise in at least one of the following:
    • Outgoing personality that can facilitate working sessions with various different business stakeholders
    • Driven, result-oriented, ambitious, and can work independently
    • A desire to continuously improve your clients, your colleagues, your company, and yourself.


  • Experience with Cloud System Validation
  • Experience with the Veeva Platform
  • Epista are only considering candidates who have the right to work in Denmark and/or Sweden.

On a typical day you would;

As a CSV consultant at Epista, you’ll be a part of the highly skilled team working at the intersection of business, compliance, and IT. You’ll be involved in a wide variety of projects, primarily focusing on acting as validation lead in system implementation projects and assignments, where you will contribute with your knowledge and expertise. Much of your time will be spent with clients – international pharma and fast-growing biotech companies. Your daily activities might include:

  • Meeting with client’s Business owners, Quality process experts, and key Quality stakeholders (“speaking the lingo of Epista’s customer”) to identify needs, visions, and struggles
  • Preparation and moderation of workshops with cross-functional participants
  • Involvement in project status meetings, status presentations, or Steering Committees
  • Development of validation strategies, prioritizing tasks, projects, and efforts to bring our customers from A to B
  • Creation of client system validation documents
  • Screening of IT application vendors, performing functionality evaluations, and giving final system recommendations
  • Supporting customers throughout a system implementation, so they can make the right configuration/system design decisions
  • Evaluating vendor assessment and vendor documentation
  • Drafting System Governance documents to secure efficient and compliant management of validated system
  • Share your experiences and lessons learned with the Epista team to make sure they are all continuously improving.

Interested? Send your CV to

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