Software Validation Specialist

VTI Life Sciences; United States; On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

401(k) matching

Professional development and training

Comprehensive benefits package

Job summary

A leading life sciences company in the United States is seeking a Computer System Validation (CSV) Specialist to ensure compliance with FDA regulations and industry standards. The ideal candidate will possess a bachelor's degree, 7+ years of relevant experience, and expertise in Software Validation. This full-time role offers competitive compensation and professional development opportunities in a collaborative environment.

Qualifications

• 7+ years of experience in FDA-regulated industry.
• Expertise in 21 CFR Part 11 and ISO 13485.
• Familiarity with Test Scripts and databases.

Responsibilities

• Develop test plans and execute qualification activities.
• Draft and review User Requirement Specifications.
• Conduct manual and automated testing.

Skills

Software Validation

Regulatory Compliance

Technical Writing

SQL Knowledge

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Oracle Agile

Jira

Valgenesis

Job description

Computer System Validation (CSV) Specialist

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.

Responsibilities

• Develop test plans, test cases, and test scripts on multiple projects simultaneously
• Schedule and execute qualification activities
• Draft and/or review User Requirement Specifications/Software Requirement Specifications
• Draft and review Software Design Specifications
• Create, track, and complete regulated documentation for the SW V&V process such as change orders, test plans, reports, and relevant attachments
• Generate and update documentation (SOPs, PFMEA, Forms, etc.)
• Attend meetings and coordinate projects
• Basic SQL knowledge (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

Qualifications

• 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 (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

Salary Range: $80,000 – $105,000 annually (W2 employee)

VTI Life Sciences strives to maintain and inspire professional excellence by providing commissioning, qualification, quality engineering, automation, and validation services to the pharmaceutical, biotechnology, biologics, and medical device industries. We offer professional development, training, competitive compensation, excellent benefits, a matching 401(k), and a stimulating, 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.

As one of the leading global commissioning, qualification, and validation services organizations, VTI is always looking for innovative, talented, and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full‑time/permanent employees. www.validation.org

Seniority Level

Mid‑Senior level

Employment Type

Full‑time