Katalyst CRO ยท 5 months ago
Validation Engineer/CSV Engineer
Walnut Creek, CA
Contract
Onsite
Mid Level
4+ years expKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions in contract research related to Clinical trials of drugs, biologics, and medical devices. The Validation Engineer/CSV Engineer will develop and maintain software quality assurance processes, ensure compliance with regulatory standards, and support audits and inspections for non-product software used in medical device development.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development
Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software
Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards
Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11
Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution
Traceability Matrix
Periodic Reviews
System Retirement/Decommissioning
Execution of Dry/Test protocol run
Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions
Perform System Retirement/Decommissioning of systems not in business
Work closely with software development and IT teams to establish best practices for quality and compliance
Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management
Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system
Qualification
Required
A Minimum bachelor's degree in engineering, Science or related technical field
Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry
Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304)
Experience with non-product software validation, including tools for development, testing, and maintenance
Good knowledge and experience of CSV activities but not limited to
GxP and 21 CFR Part 11 applicability/criticality assessment
Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc
Execution of Dry/Test protocols
Conduct Periodic Reviews of systems
Perform System Retirement of systems that are not in business
Understanding of Medical Device Quality and Compliance
Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines
Working experience in Product Lifecycle Management (PLM) tool
Sound knowledge of computer system development lifecycles
Preferred
Knowledge of JIRA, JAMA software and test automation is a plus
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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