Validation Specialist

vor 4 Wochen


YverdonlesBains, Waadt, Schweiz gloor&lang AG Vollzeit
12 months contractor – French speaking necessary

Our client, a leading biopharmaceutical company, is seeking a highly skilled Validation Specialist to join their team at their new commercial manufacturing site. As a key member of the Center of Excellence for projects and New Product Introductions (NPIs), you will be responsible for ensuring that products and processes meet regulatory requirements and quality standards.

You will support all operational aspects of the MS&T department, including process monitoring, change control, and deviation closure. This role requires strong collaboration with cross-functional teams, including Manufacturing, Quality, Logistics, Facilities, Drug Product Development, and Vendors.

Key responsibilities include:

  • Developing and implementing site process validation and revalidation strategies to meet cGMP and quality requirements.
  • Collaborating with cross-functional teams to define interfaces for equipment qualification, system qualification, and analytical method validation.
  • Establishing and maintaining the Validation Master Plan for process validation.
  • Participating in transfers and launches, and aligning with technical development for new products.
  • Authoring or reviewing routine validation protocols and reports, associated change controls, and supporting execution at the shop floor.
  • Leading and driving investigations for validation-related matters and implementing corrective and preventive actions.
  • Contributing to all relevant audit inspections and ensuring inspection readiness for the site.
  • Initiating, driving, and implementing continuous improvement initiatives to optimize processes, enhance product performance, and drive operational excellence.

You will be able to work independently and influence and work across organizational boundaries. Strong interpersonal and communication skills, a team player attitude, and a willingness to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Excellent command of English and preferably French language.

gloor&lang AG is the right choice in consultation for life science talents.


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