Senior Process Validation Specialist

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Responsibilities and activities are focused on scientific and regulatory expertise within the field of process validation.

Key responsibilities:

1. Develop the strategy for the process-specific validations in biotechnology processes with focus on Mammalian Large Scale (ORCA).
2. Issue process validation/study protocols and reports following Lonza VMP and SOPs (e.g., hold time studies, resin lifetime studies, buffer hold studies, mixing studies, etc.).
3. Participate in or moderate cross-functional Risk Assessments (RA) to define the scope of validation/study activities.
4. Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans, as well as the definition of corrective measures.
5. Collaborate with QA to define the content, wording, and scope of validation documents, ensuring compliance with standards.
6. Issue, review, or approve project-related documents (RA, TT documents, FMEA, etc.) and records (DR, CR, TCR).
7. Assess validation-related technical change requests (TCR) and process-specific change requests (CR) to determine if additional validation is required.
8. Coordinate with QA Ops for batch release of validated processes, including approval of deviation reports and change requests.
9. Prepare, process, control, and approve CPV plans, CPV reports, and PQRs as a process validation specialist.
10. Assist process development during process characterization studies and risk assessments.
11. Act as a technical lead in cross-functional project teams, organizing meetings for effective collaboration with MSAT, QA Validation, Cleaning Validation, and QA Qualification.
12. Serve as a contact for process validation during inspections by authorities or customer audits.
13. Support validation training programs and mentor junior employees.
14. Support the establishment of a culture of continuous improvement.

Home office possible.

Contact: Alba Jansa

Whatsapp Business: +41 76 811 63 99