Talent.com
Senior Software Validation Engineer
Senior Software Validation EngineerStaftonic LLC • Sonoma, CA, United States
serp_jobs.error_messages.no_longer_accepting
Senior Software Validation Engineer

Senior Software Validation Engineer

Staftonic LLC • Sonoma, CA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Title : Senior Software Validation Engineer

Location : San Francisco Bay Area

Long Term Project

Key Responsibilities :

  • Apply and promote best-practice use of internal Quality Management System to
  • ensure regulatory compliance.
  • Lead validation efforts for GxP-regulated computerized systems used acrossthe
  • organization including quality, manufacturing, clinical, business systems, etc.
  • Develop and improve non-product software validation procedures, templates,
  • and maintain the software master validation plan.
  • Write validation plans, protocols, reports for non-product computer software
  • validation.
  • Review and approve validation plans, protocols, executed validation protocols
  • and summary reports.
  • Collaborate with software owners to write intended uses, user requirements, risk
  • analysis, and system requirements.
  • Evaluate software changes to determine if re-validation is required.
  • Manage validation timelines and deliverables to drive completion of software
  • validation activities.
  • Responsible for other duties as assigned which may include, but is not limited to
  • supporting processes within training, document control, audits, and CAPA.
  • Support and improve change control processes related to validated systems.
  • Ensure validation aligns with internal procedures and external regulatory
  • expectations, including GAMP 5 and 21 CFR Part 11.
  • Collaborate with IT, QA, Engineering, Manufacturing, Clinical, and external
  • vendors to ensure validation activities are executed effectively, efficiently and
  • meet regulatory requirements.
  • Mentor junior staff and cross-functional team members on computer software
  • validation best practices and data integrity principles.

Qualifications and Experience :

  • Bachelor’s in engineering, Computer Science, Information Technology, or Life
  • Sciences, etc.
  • Minimum of 6 years of Engineering work experience with a BS in the medical
  • device or similarly regulated industry
  • Preferred 3 years’ experience in a software validation function in a regulated
  • environment
  • Deep understanding of GAMP 5, 21 CFR Part 11, Annex 11, and ISO 13485.
  • Experience implementing and validating systems in a cloud / SaaS environment.
  • Experienced in Microsoft Office, Google Suite, Jama, and ePLM / eQMS systems.
  • Must be a self-starter, team builder, and excellent in verbal and written
  • communication.
  • Preferred Certifications : GAMP Practitioner, PMP, ASQ-CQA, etc.
  • serp_jobs.job_alerts.create_a_job

    Validation Engineer • Sonoma, CA, United States

    Job_description.internal_linking.related_jobs
    Engineer, QA Validation / Validation Engineer (QA / GMP)

    Engineer, QA Validation / Validation Engineer (QA / GMP)

    Tap Growth ai • Novato, California, US
    serp_jobs.job_card.full_time
    We're Hiring : Engineer, QA Validation! 🌟.Review and approve user requirement specifications, automation functional requirement. Review and approve FAT’s, SAT’s, Commissioning and Automation Accepta...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Senior Software Engineer

    Senior Software Engineer

    Eluvio, Inc. • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    You will have the opportunity to work with some of the most skilled software engineers in the industry and will be involved in the early phases of building a multi-faceted decentralized platform.Id...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Software Engineer, Credit Execution

    Senior Software Engineer, Credit Execution

    The Voleon Group • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    Senior Software Engineer, Credit Execution.Senior Software Engineer, Credit Execution.Continue with Google Continue with Google. Senior Software Engineer, Credit Execution.Senior Software Engineer, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Software Engineer, Core Experiences - Berkeley, USA

    Senior Software Engineer, Core Experiences - Berkeley, USA

    Clutch Canada • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    Speechify is the easiest way to listen to the world’s information.Articles on the web, documents in the cloud, books on your phone. We absorb it all and let you listen to it at your desk, on the go,...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Software Engineer II - 2317513

    Senior Software Engineer II - 2317513

    UnitedHealth Group • Richmond, CA, United States
    serp_jobs.job_card.full_time
    Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives.The work you do with our team will directly improve health outcomes by connect...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Software Engineer, AI

    Senior Software Engineer, AI

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Software Engineer, AI Applications.Key Responsibilities Develop and refine effective prompts for various AI use cases Collaborate with the AI Native team to dep...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Software Engineer, Endpoint

    Senior Software Engineer, Endpoint

    Tanium • Emeryville, CA, United States
    serp_jobs.job_card.full_time
    As a Tanium Senior Software Engineer focused on Endpoint development, you will build and maintain best-of-breed services that power products as part of a nimble development team.Tanium focuses on a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Robotics Software Engineer

    Senior Robotics Software Engineer

    Emancro • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    Emancro’s mission is to build general-purpose hospital logistics robots that perform a wide variety of tasks such as organizing and distributing medication and medical supplies within hospitals, an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Software Engineer, Integration

    Software Engineer, Integration

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for an Autonomy Software Engineer, Integration.Key Responsibilities Develop interfaces between autonomy software components, sensors, and the remote dispatch system Design, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Senior Software Engineer

    Senior Software Engineer

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Software Engineer, Behavior Validation.Key Responsibilities Develop and prototype strategies to benchmark autonomy systems' performance Convert validation strat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Robotics Software Engineer

    Senior Robotics Software Engineer

    Ambi Robotics • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    Senior Robotics Software Engineer role at Ambi Robotics.Ambi Robotics is a well-funded startup focused on making e-commerce logistics more efficient and human-friendly with AI-powered robotics.We a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Verification Validation Engineer, Medical Device

    Verification Validation Engineer, Medical Device

    SciPro • Santa Rosa, CA, United States
    serp_jobs.job_card.full_time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Validation : .P...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Senior Software Engineer

    Senior Software Engineer

    Djangojobs • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    Fueled by an innovative drive and a deep understanding of the soil microbiome, Pivot Bio is pioneering game-changing advances in agriculture. Our first commercial product harnesses the power of natu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Senior Firmware Engineer

    Senior Firmware Engineer

    Form Energy • Berkeley, CA, United States
    serp_jobs.job_card.full_time
    Are you ready to build America’s energy future? Form Energy is an American manufacturing and energy technology company.We’re revolutionizing energy storage with cost-effective, multi-day technology...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Software Validation Engineer

    Software Validation Engineer

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Software Validation Engineer to ensure the verification and validation of automation tools and computational biology software. Key Responsibilities Collaborate with soft...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Software Engineer IV

    Software Engineer IV

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Software Engineer IV with expertise in HP NonStop systems.Key Responsibilities Design, code, test, and deploy COBOL and TAL programs on HP NonStop systems Support and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Backend Software Engineer

    Senior Backend Software Engineer

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Backend Product Software Engineer, Storage Management.Key Responsibilities Deliver ongoing business impact across a team, product capability, or technical system...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior AI Software Engineer

    Senior AI Software Engineer

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior AI Software Engineer to enhance developer experience through AI-powered tools and workflows. Key Responsibilities Design, build, and maintain AI-augmented develop...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Engineer

    Senior Engineer

    VirtualVocations • Concord, California, United States
    serp_jobs.job_card.full_time
    Engineer who will serve as a technical expert in application and systems engineering.Key Responsibilities Design and develop business-critical software solutions based on IT strategy Collaborate...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Software Engineer

    Senior Software Engineer

    PG Forsta • Emeryville, CA, United States
    serp_jobs.job_card.full_time
    PG Forsta is the leading experience measurement, data analytics, and insights provider for complex industries-a status we earned over decades of deep partnership with clients to help them understan...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted