Specialist, Validation

China, Guangzhou

Today, Lonza is a global leader in life sciences operating across three continents. 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.

Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market. You need to monitor day-to-day Validation activities in accordance with approved Standard Operation Procedure / Plan / Policies for a small scale, multi-product, Good Manufacture Practices biotech contract development/manufacturing facility.

Key responsibilities:

  • Monitor day-to-day Validation activities in accordance with approved Standard Operation Procedure / Plan / Policies for a small scale, multi-product, Good Manufacture Practices biotech contract development/manufacturing facility
  • Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
  • Support / participate in validation activities during facility startup / shutdown / changeover and routine Good Manufacture Practices operations
  • Support / participate in Site Validation Maintenance Program and implementation of department training requirements
  • Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines
  • Active co-ordination with internal and external validation resources to achieve department / project goals
  • Liaise with system owners, quality unit and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectations
  • Review & assess Site Change Controls, implementation of Validation Corrective And Preventive Actions and subsequent closure
  • Participate in Customer / Agency Audits and Inspections as required
  • Participate in on-job training program for staff and provide guidance to team members as Required
  • Any other tasks as and when assigned by supervisor.

Key requirements:

  • Familiarity with Regulatory requirements and local Codes & Standards (e. g. , Food and Drug Administration, European Agency for the Evaluation of Medicinal, Good Automated Manufacturing Practice, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
  • Good knowledge and experience of the practical and theoretical requirement of validation
  • program in Good Manufacture Practices facility
  • Good leadership skills
  • Strong interpersonal skills
  • Effective Communicator (oral and written)
  • Exhibit good quality decision making traits
  • Meticulous and Systematic
  • Analytical Mind
  • Ability to define specific goals clearly, to develop and prioritize activities
  • Team player, with strong focus on safety, quality and timelines

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.

Reference: R27531