Overview
Sr. Validation Engineer/CSV decommissioning Jobs in Los Angeles, California, USA at ZipRecruiter
Position: Sr. Validation Engineer (CSV) with decommissioning experience
Looking for profiles having around 10-12 years of overall experience
Responsibilities:
Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments)
Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans
Providing leadership, oversight, and training related to validation activities to multi-functional teams
Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP)
Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements
Working with appropriate teams to establish quality expectations related to validation planning and execution
Participating with stakeholders in the preparation of software specification documents, risk management and validation plans
Participating in developing qualification processes and implementing standard operating procedures
Participate in execution of gap assessment and remediation activities
Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols
Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities
Preparing for and participating in external/internal computer system/software audits
Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise
Contributing to process improvements by developing and updating written procedures related to computer systems
Skill Competencies
At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry
Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques
Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality
Demonstrated project management and leadership skills
Proficiency in interacting with contacts, including project teams and vendors
Certified auditor or equivalent experience conducting software-vendor quality audits
Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives
Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP
Experience with the following software systems/applications:
Quality Management System
Document Management System
Validation Management System
Bachelor’s/master’s degree in computer science engineering or equivalent
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Title: Sr. Validation Engineer/CSV decommissioning
Company: ZipRecruiter
Location: Los Angeles, California, USA
Category: Quality Assurance – QA/QC
