Company:
Katalyst Healthcares & Life Sciences
Location: Bothell
Closing Date: 04/08/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
RESPONSIBILITIES:
" Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
" Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
" Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
" Author, review and/or approve applicable CSV documentation.
" Perform or oversee test script execution efforts, including defect management.
" Ensure validation test strategies align with internal procedures and requirements for intended use.
" Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
" Experience in following CSV methodology for system evaluations, changes, and implementations.
" Ability to work independently.
Requirements:
Education: Master's Degree with 2+ years of direct experience in Validation in pharmaceutical, biotechnology.
Related industry, preferably in FDA-regulated environments.
Bachelor's Degree with 4+ years of direct experience in Validation.
Pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
3-5+ years' experience in performing periodic review of computerized systems.
Experience with Val genesis/Veeva Vault CR/PR/CAPA systems.
Strong critical thinking and problem-solving skills.
Strong interpersonal skills to work with teams in different functions and organizations GXP Equipment Validation.
" Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
" Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
" Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
" Author, review and/or approve applicable CSV documentation.
" Perform or oversee test script execution efforts, including defect management.
" Ensure validation test strategies align with internal procedures and requirements for intended use.
" Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
" Experience in following CSV methodology for system evaluations, changes, and implementations.
" Ability to work independently.
Requirements:
Education: Master's Degree with 2+ years of direct experience in Validation in pharmaceutical, biotechnology.
Related industry, preferably in FDA-regulated environments.
Bachelor's Degree with 4+ years of direct experience in Validation.
Pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
3-5+ years' experience in performing periodic review of computerized systems.
Experience with Val genesis/Veeva Vault CR/PR/CAPA systems.
Strong critical thinking and problem-solving skills.
Strong interpersonal skills to work with teams in different functions and organizations GXP Equipment Validation.
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