CSV Senior Manager

Highly Competitive
  1. Permanent
  2. Validation
  3. Iceland
Höfuðborgarsvæði, Ísland
Posting date: 09 Jan 2024

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a CSV Senior Manager to join a biotech organisation on a permanent basis located in Iceland.


  • Handle and monitor the implementation of validation protocols, guaranteeing accomplishment and documentation of validation actions in a timely manner.
  • Stay updated on industry regulations, guidelines and best practices linked to CSV and incorporate them into the business's procedure.
  • Perform risk assessments as well as offer leadership on risk mitigation methods linked to computerised systems.
  • Write validation plans, IQ, OQ, PQ protocols and validation reports for multiple computerised systems.
  • Evaluate and sign off on user requirement specifications, functional specifications and design specifications connected to computerised systems.
  • Work alongside cross-functional teams to outline validation needs for new equipment, systems and system upgrades.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a computer science, engineering, life science or similar discipline, though an advanced degree would be more ideal.
  • Demonstrable experience within computerised systems validation in a regulated organisation such as pharmaceuticals, biotechnology, medical devices, etc.
  • Expertise on regulatory needs such as FDA, EMA, etc., as well as industry standards such as GAMP 5, 21 CFR Part 11, etc. connected to CSV.
  • Leadership and project management abilities with the capacity to efficiently guide a team and handle various projects concurrently.
  • Communication skills both verbally and in writing.
  • Works well with others in cross-functional teams and regulatory agencies.
  • Familiarity with validation documentation risk assessments and validation implementation.
  • Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.