Instrument Software Validation CSV Lead

Intellectt Inc; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company in Engineering Services seeks a Senior Engineering Recruiter to take charge of Instrument Software Validation processes. You will collaborate closely with cross-functional teams to ensure compliance with regulatory standards, contributing to the advancement of medical devices and aerospace technologies. Ideal candidates will possess significant CSV expertise, a robust understanding of regulatory frameworks, and excellent problem-solving skills, fostering an environment of continuous improvement and compliance.

Qualifications

• 5–7 years of hands-on experience in CSV, especially for instrument software.
• Deep understanding of European regulatory requirements (EMA, GxP).
• Experience with lab systems, clinical trials, and infrastructure validation.

Responsibilities

• Lead Computer System Validation (CSV) for instrument software projects.
• Develop and execute validation plans, protocols, and reports.
• Conduct risk assessments and maintain traceable documentation.

Skills

Attention to detail

Problem-solving

Communication

Collaboration

Regulatory compliance

Education

Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field

Master’s degree or higher in a relevant field (preferred)

Tools

CSV

GAMP

Agile methodologies

Job description

6 days ago Be among the first 25 applicants

Direct message the job poster from Intellectt Inc

Senior Engineering Recruiter | Medical Device | Aerospace | Automotive

Role: Instrument Software Validation CSV Lead

Location: Remote

Key Responsibilities

• Lead Computer System Validation (CSV) efforts for instrument software projects, ensuring full alignment with EMA and GxP guidelines.
• Develop and execute validation plans, protocols, and reports in accordance with regulatory standards.
• Analyze and document business needs, converting them into technical validation deliverables.
• Validate instrumentation systems and infrastructure to ensure business and regulatory compliance.
• Apply deep knowledge of lab systems and clinical trial processes to align validation activities with industry best practices.
• Conduct risk assessments and impact analyses to identify and resolve validation gaps.
• Maintain detailed and traceable documentation throughout the project lifecycle.
• Monitor and implement changes based on evolving regulatory trends and industry standards.

What You Bring

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
• 5–7 years of hands-on experience in CSV, especially for instrument software.
• Deep understanding of European regulatory requirements (EMA, GxP).
• Strong background as a Business Analyst, capable of translating business needs into technical outcomes.
• Experience with lab systems, clinical trials, and infrastructure validation.
• Excellent attention to detail and problem-solving abilities.
• Strong communication and collaboration skills across functional teams.
• Ability to multi-task and manage priorities in a dynamic environment.

Preferred Qualifications

• Master’s degree or higher in a relevant field.
• Certifications in CSV, GAMP, or regulatory compliance.
• Direct experience with regulatory audits and inspections.
• Familiarity with Agile methodologies and SDLC in regulated environments.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Engineering Services, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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