CSV Automation Specialist

VTI Life Sciences-posted about 2 months ago
$80,000 - $105,000/Yr
Full-time • Mid Level
San Diego, CA
51-100 employees
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VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems.

  • Develops test plans, test cases, and test scripts on multiple projects simultaneously.
  • Scheduling and execution of qualification activities
  • Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications.
  • Software Design Specification drafting and review.
  • Create, track, and complete regulated documentation for SW V&V process such as change orders, test plans, reports, and relevant attachments.
  • Documentation generation and updates (SOPs, PFMEA, Forms, etc.)
  • Meeting attendance and project coordination.
  • Basic SQL Knowledge for (SELECTS, JOINS, and execution queries).
  • Identify defects and track them from discovery to resolution.
  • Conduct manual and automated testing of software.
  • Work with developers to perform root-cause analysis and preliminary problem diagnosis.
  • Provide all services in accordance with FDA cGxP guidelines and regulations.
  • Bachelor's degree or higher in Engineering, Life Sciences, or related discipline.
  • 7+ years of relevant FDA-regulated industry experience in Software Validation.
  • Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485, ISA 95, and GAMP 5.
  • Familiarity with Test Scripts, web reports, and databases.
  • 5+ years of proven experience with web reports, SQL queries, and Computerized Systems Validation.
  • Must have experience working in an FDA-regulated environment.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, etc.
  • Exceptional technical writing, review, and analytical skills.
  • Experience with document control systems (Oracle Agile, Valgenesis, JAMA, etc)
  • Experience with issue tracking systems (Jira, Bugzilla)
  • Knowledge of SDLC
  • VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment.
  • We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
  • We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
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