2022-07-29 11:26:48

Validation Engineer

CVMarket.lt klientas
1800 - 2600 €/m Gross

Job Description

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.


We are recruiting for a Validation Engineer to work within the Engineering team, based in Vilnius. 


How you’ll spend your day

  • Lead and execute validation efforts for computerized systems to ensure compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
  • Develop, review, and approve validation documentation such as Validation Plans, Risk Assessments, Requirement Specifications, Test Protocols, and Validation Reports.
  • Conduct periodic reviews of validated systems to ensure ongoing compliance and revalidate as necessary.
  • Collaborate with cross-functional teams, including IT, QA, and Operations, to ensure aligned validation strategies and seamless project execution.
  • Investigate and address discrepancies or anomalies during validation activities.
  • Stay updated with emerging regulations and best practices in computerized system validation.
  • Conduct training for relevant stakeholders on CSV principles and best practices.
  • Support internal and external audits by providing expertise and documentation related to computerized system validations.


 Your experience and qualifications

  • Technical or scientific education (preferably in the field of Engineering, IT, Life Science or similar). You can be last year student.
  • Excellent computer skills (MS Office and general windows applications)
  • Able to work independently, systematize and summarize information in written and verbal format
  • Strong analytical, problem-solving, and organizational skills.
  • Effective communication skills, both written and verbal.
  • Familiarity with various software development lifecycles, engineering solutions, equipment, processes.
  • Good English and Lithuanian language
  • Advantage: Initial experience in computer system validation in the pharmaceutical sector, GMP guidelines, and knowledge of GAMP5

Company offers

 Enjoy a more rewarding choice

  • Salary between 1800 - 2600 Euro gross monthly. 
  • Benefits package: health and accident insurance, additional health and vacation days (for worked years)
  • Highly professional team and organizational culture with strong values
  • Personal and professional development within the company
  • Work model supporting work life balance
  • Employee rewards and recognition programs, events and social activities