Validation Engineer/CSV EngineerKatalyst Healthcares and Life Sciences • Walnut Creek, CA, United States
[error_messages.no_longer_accepting]
Validation Engineer / CSV Engineer
Katalyst Healthcares and Life Sciences • Walnut Creek, CA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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. 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) too. sound knowledge of computer system development lifecycles. Knowledge of JIRA, JAMA software and test automation is a plus. " Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.
Job Description :
- 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.
Responsibilities :
Requirements :
[job_alerts.create_a_job]
Validation Engineer • Walnut Creek, CA, United States
[internal_linking.similar_jobs]
We are seeking an experienced Staff Engineer to join our innovative AI datacenter team.In this role, you will play a pivotal role in ensuring the reliability, efficiency, and scalability of our ups...[show_more]
Licensed Clinical Social Worker (LCSW).AlliedTravelCareers is working with Cynet Health to find a qualified Licensed Clinical Social Worker in Vacaville, California, 95696!.Job Title : PSYL Profes...[show_more]
Working within Bio-Rad's Life Science R&D Group as a Systems Engineer, you will take engineering concepts, requirements and transform them into functional prototypes and finished products that impr...[show_more]
The Operations Supervisor- Nutrition Services, reporting to the Operations Manager, plans and oversees the activities of the nutrition staff at John Muir Health, at the Walnut Creek Campus, Concord...[show_more]
Senior Automation Validation Engineer (Biotech / Pharma).Location - California Bay Area.Please note : We are only considering W2 candidates at this time.
Applications from third-party vendors or C2C ar...[show_more] Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.Coordinate with laboratory personnel to define qualification requirements.Coordinate equipment qua...[show_more] 
We are currently seeking an experienced.The ideal candidate will have hands-on experience with complex.Please note that this position requires the selected individual to be.Hands-on experience in i...[show_more]
Certified Registered Nurse Anesthetist | General Practice.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with GHR Healthcare to find a qualified General Practice CRNA in V...[show_more]
Join ERM and be part of a global team delivering innovative air quality and climate solutions for the world's most dynamic industries.
Why This Role Matters At ERM, we're shaping the future of envi...[show_more]
TetraMem is a fast-growing well-funded startup company working on the next generation of computing platforms with unique ReRAM-based in-memory computing technologies.
In this role, you will be respo...[show_more]
Develop and implement mixed-signal verification and coverage plans for complex IC designs based on design architecture and specifications.
Design and develop verification testbenches using industry-...[show_more]
Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.Coordinate with laboratory personnel to define qualification requirements.Author, review and execu...[show_more]
Software Quality Assurance Specialist.Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
Ensure adherence to regulator...[show_more]
We are seeking a highly experienced and efficient.Senior Software Validation Engineer, Manufacturing.This critical role focuses on the validation and compliance of non-product, business-critical co...[show_more]
Primary Duties & Responsibilities.Assist in the standardization and implementation of Switch-based DVT (.T optical transceiver products.
This includes continuously defining the new test coverage and...[show_more]
Fully on-site at our Walnut Creek clinic.Monday-Friday, 7 : 30am-4 : 00pm or 8am-4 : 30pm.The Clinical Supervisor is responsible for the cognitive behavioral therapy and clinical services provided at Rog...[show_more]
Automation CSV Engineer (Biotech / Pharma).Location – California Bay Area.Please note : We are only considering W2 candidates at this time.
Applications from third-party vendors or C2C arrangemen...[show_more]
Be responsible for test validation of hardware / software components related to ADAS / AD highway driving & safety functions such as Adaptive Cruise Control, Highway Assist, Lane Change Assist, Lane De...[show_more]
Staff Datacenter Systems Validation Engineer
Tesla • Fremont, CA, United States
[job_card.full_time]
[last_updated.last_updated_1_hour] • [promoted] • [new]
Travel Licensed Clinical Social Worker (LCSW) - $3,424 per week in Vacaville, CA
AlliedTravelCareers • Vacaville, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Staff Systems Engineer
Bio-Rad Laboratories • Pleasanton, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Supervisor - CMC Nutrition Services - Full Time - 8 Hour - Variable Shift
John Muir Health • Concord, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Senior Automation Validation Engineer
Trinity Consultants • Hayward, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Validation Engineer II
Katalyst Healthcares and Life Sciences • Fairfield, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Sr. CSV Engineer
Kasmo Global • Vacaville, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Locum Certified Registered Nurse Anesthetist (CRNA) - General Practice in Vacaville, CA
LocumJobsOnline • Vacaville, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Managing Consultant, Environmental Air Quality, Engineering or Science
ERM • Walnut Creek, CA, United States
[job_card.temporary]
[last_updated.last_updated_1_day] • [promoted]
Analog / Mixed-Signal IC Verification Engineer
TetraMem INC • Fremont, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Analog / Mixed-Signal Verification Engineer
NR Consulting • Fremont, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Validation Engineer II
Ageatia Global Solutions • Vacaville, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Validation Engineer / CSV Engineer
Katalyst HealthCares & Life Sciences • Walnut Creek, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Senior Software Validation Engineer, Manufacturing
10X Genomics • Pleasanton, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Principal System Validation Engineer
Coherent • Fremont, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Clinical Supervisor
Rogers Behavioral Health • Walnut Creek, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Automation CVS Engineer
Trinity Consultants - Advent Engineering • Fremont, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Sr. Validation Engineer, ADAS / AD
Tranzeal • Newark, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]