Senior Process Validation Specialist

Location: Visp

Home office: 2 days a week

Contract duration: 6 months

Key responsibilities:

• Develop the strategy for the process-specific validations in biotechnology processes.
• Issue process validation/ study protocols and reports following VMP and SOPs (e.g. hold time studies, resin lifetime studies, buffer hold studies mixing studies, etc.)
• Participate in or moderate cross-functional Risk Assessments (RA) to define the scope of validation/ study activities
• 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 associated corrective measures
• Collaborate with QA in the definition of the standard for content, wording and scope of the validation documents and ensure that all validation documents comply with this standard
• Issue, review or approve project related documents (RA, , TT documents, FMEA, etc.) and records (DR, CR, TCR).
• Assessment of validation related technical change requests (TCR) and process-specific change requests (CR). Assessment of whether additional / new validation is required.
• Ensure the collaboration with QA Ops for batch release of process in validation, inclusive the approval of deviation reports and change request of validated processes.
• Coordinates preparation, processing, control and approval of CPV plans, CPV reports and PQRs as process validation specialist.
• Assist process development (PD) during process characterization studies and risk assessments
• Act as a key member (i.e. technical lead) in cross-functional technical project teams and ensure the organization of meetings for an efficient collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification (as required).
• Contact for process validation during inspections by authorities or customer audits.
• Support (if needed) validation training programs and train/ mentor junior employees
• Support (as requested) the establishment of a culture of continuous improvement throughout the organization

Requirements:

• Master’s degree (or higher) in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related life science field.
• Minimum of 5 years of relevant experience in process validation within the biopharmaceutical industry.
• Deep knowledge of GMP guidelines and ICH, EMA, and FDA regulations related to process validation