Specialist, Validation

China, Guangzhou

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.

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 SOPs / Plan / Policies for a small scale, multi-product, GMP biotech contract development/manufacturing facility.

Key responsibilities:

  • Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a small scale, multi-product, GMP 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 GMP operations
  • Support / participate in Site Validation Maintenance Program and implementation of department training requirements
  • Develop Validation Plans for a change implementation project as required
  • 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 CAPAs and subsequent closure
  • Participate in Customer / Agency Audits and Inspections as required
  • Participate in on-job training program for staff
  • Any other tasks as and when assigned by supervisor

Key requirements:

  • Familiarity with Regulatory requirements and local Codes & Standards (e.g.FDA, EMEA,GAMP and ICHQ7)
  • Good knowledge and experience of the practical and theoretical requirement of validation
  • Program in GMP 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

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: R27516