Senior Process Validation Specialist
Location: Visp
Sector: Computer System Validation & Quality Assurance
Job Type: contract
Salary: Negotiable
Reference: BBBH614387
Description:
Responsibilities and activities are focused on scientific and regulatory expertise within the field of process validation.
Key responsibilities:
Develop the strategy for the process-specific validations in biotechnology processes with focus on Mammalian Large Scale (ORCA).
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.)
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 Lonza employees
Support (as requested) the establishment of a culture of continuous improvement throughout the organization
Home office possible
Key responsibilities:
Develop the strategy for the process-specific validations in biotechnology processes with focus on Mammalian Large Scale (ORCA).
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.)
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 Lonza employees
Support (as requested) the establishment of a culture of continuous improvement throughout the organization
Home office possible
Contact: Alba Jansa
Whatsapp Business: +41 76 811 63 99
