Validation Specialist

United States, Walkersville (Maryland)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

To implement, and maintain the computer systems quality and validation for computerized systems. Develop and execute Validation plans and Qualification protocols for GxP computerized systems to provide a high degree of assurance that the computerized system will consistently function in accordance with predetermined specification, performance, and quality attributes

Key responsibilities:

  • To coordinate the validation of GMP relevant computer systems within the Walkersville site, in line with internal and external, global and local guidelines
  • Ensure that adequate standards are maintained, communicated and effectively implemented for all systems and associated computer infrastructure.
  • Consult and advise computer systems projects on the correct application of internal and external regulations
  • Understanding of Data Integrity and how to apply and implement Data Integrity with GxP computerized systems.
  • Provide a high level of technical expertise to support the discovery, validation, and implementation of computer systems and applications.
  • Determine risk, requirements, verification activities, and acceptance criteria for a given computerized system to ensure compliance requirements are met and that risk-mitigations, verification activities, and acceptance criteria are sufficient for the system to be considered fit for intended purpose.
  • Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans.
  • Perform validation of spreadsheets
  • Review systems to ensure compliance with Lonza and industry data integrity standards. Develop and implement action plans to ensure continued compliance. Perform other duties as assigned.
  • Decides the minimum level of qualification and validation necessary for local systems to ensure compliance with all relevant regulations and industry guidance documents, as well as internal local and global regulations
  • Provides expert technical IT guidance to the Head of Quality for GMP decisions regarding the validation of computerized systems
  • Ensure that the change management process for evaluating new or revised software is implemented and that the appropriate validation activities are identified and carried out

Key requirements:

  • Bachelor’s degree in life sciences or Computer science.
  • GMP compliance knowledge including knowledge Part 11 compliance knowledge preferred. Comprehensive knowledge of Validation lifecycles for Computerized Systems and Process Control System.
  • Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500, and data integrity requirements

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R23127