Job Title: Senior Validation Specialist
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Description: Our client is seeking a Senior Validation Specialist on a contract basis. The role involves developing strategies for process-specific validations in biotechnology, focusing on Mammalian Large Scale processes.
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Main Responsibilities:
1. Develop validation protocols and reports in accordance with company SOPs, including hold time, resin lifetime, buffer hold, and mixing studies.
2. Participate in risk assessments to define validation scope.
3. Assess validation data for compliance and support investigations into deviations.
4. Collaborate with quality teams to ensure validation documents meet standards.
5. Review and approve project documents and records.
6. Evaluate change requests and determine if additional validation is needed.
7. Coordinate batch release, deviations, and change management.
8. Manage CPV plans and reports.
9. Assist in process development and characterization studies.
10. Lead technical project teams and organize meetings with other departments.
11. Serve as the contact during inspections.
12. Support validation training and mentor junior staff.
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Qualifications and Experience:
* A master's degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent.
* Experience in project management within operations, MSAT, Quality, or Compliance.
* Interaction with regulatory agencies (Swissmedic, FDA) is advantageous.
* Mammalian cell process experience is a plus.
* Strong multitasking and deadline management skills are required.
* Proficiency in English; German skills are a plus.
* A Swiss/EU work permit or citizenship is required.