Katalyst Healthcare & Life Sciences

Clinical trial management software and consulting

Validation Engineer/CSV Engineer

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeWalnut Creek, CA, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in engineering, science, or a related technical field is required.
A minimum of 4–5 years of experience in software quality assurance or software validation is required; medical device industry experience is preferred.
Strong understanding of quality standards and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
Experience validating non-product software, including tools for development, testing, and maintenance.
Knowledge and experience with computerized system validation activities.
Ability to assess GxP and 21 CFR Part 11 applicability and criticality.
Ability to identify, prepare, and review validation deliverables, including requirements, plans, protocols, test specifications, reports, and traceability matrices.
Experience executing dry/test protocols.
Experience conducting periodic system reviews.
Experience retiring systems that are no longer in business use.
Understanding of medical device quality and compliance.
Knowledge of GxP, GAMP, and 21 CFR Part 11 guidelines.
Working experience with a Product Lifecycle Management tool.
Knowledge of computer system development lifecycles.

Responsibilities

Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
Ensure non-product software adheres to regulatory standards, including FDA, ISO 13485, and IEC 62304, and to industry best practices.
Support regulatory audits and inspections by ensuring non-product software systems comply with quality and documentation standards.
Ensure computerized systems are appropriately validated, including assessing GxP and 21 CFR Part 11 applicability and criticality.
Create and review validation deliverables, including requirement specifications, qualification protocols, reports, traceability matrices, and periodic reviews.
Execute dry/test protocol runs and prepare reports summarizing protocol execution and exceptions.
Conduct periodic reviews to determine whether systems remain in a validated state and take appropriate actions.
Retire or decommission systems that are no longer in business use.
Work with software development and IT teams to establish quality and compliance best practices.
Provide expertise and guidance on quality assurance processes for non-product software management.
Drive continuous improvement initiatives in software development processes aligned with the company's quality management system.

Desired Qualifications

Knowledge of JIRA and JAMA software.
Experience with test automation.

Job Description

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.

Requirements:

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.
Knowledge of JIRA, JAMA software and test automation is a plus.

Qualifications

Additional Information

All your information will be kept confidential according to EEO guidelines.

About the Company

Katalyst Healthcare & Life Sciences

Clinical trial management software and consulting

Katalyst Healthcare & Life Sciences offers EasyCDM Suite, a Clinical Trial Management Solution paired with consulting services to manage the full trial lifecycle. The platform covers study design, electronic data capture, medical coding, and data management, with implementation and optimization support from a consulting team. It differentiates itself by providing an all-in-one, configurable suite combined with industry-specific consulting across pharma, biopharma, medical devices, cosmeceuticals, and food/bev sectors. Its goal is to simplify business challenges and accelerate safe, effective development to improve global health.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: South Plainfield, NJ
Founded: 2016

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