Computer System Validation (CSV) Engineer | Boca Raton, Florida (Onsite)

📍 Location

Boca Raton, Florida, United States (Onsite)

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🗂 Job Category

• Engineering & Technical
• Healthcare & Medical
• Science & Research
• Information Technology (IT) & Software

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🧾 Job Overview

We are hiring a Computer System Validation (CSV) Engineer for an onsite role in Boca Raton, Florida. This position is ideal for professionals with expertise in validation processes, regulatory compliance, and quality assurance within regulated industries such as healthcare, pharmaceuticals, or life sciences.

As a CSV Engineer, you will be responsible for ensuring that computer systems and software applications meet regulatory standards and operate reliably within validated environments. The role involves working closely with cross-functional teams to validate systems, document processes, and maintain compliance with industry standards.

This opportunity offers strong career growth in validation engineering, regulatory compliance, and quality assurance. Candidates will gain exposure to industry best practices, validation frameworks, and certification opportunities in compliance standards such as GxP, FDA regulations, and system validation methodologies.

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🛠 Key Responsibilities

• Perform computer system validation (CSV) activities for software and IT systems
• Develop and execute validation protocols including IQ, OQ, and PQ
• Ensure compliance with regulatory standards such as GxP and FDA guidelines
• Prepare and maintain validation documentation and reports
• Collaborate with IT, QA, and business teams to validate system requirements
• Conduct risk assessments and gap analysis for system validation
• Support audits and regulatory inspections
• Ensure data integrity and system reliability

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🎓 Requirements & Qualifications

Education:

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

Experience:

• 3+ years of experience in Computer System Validation (CSV) or validation engineering

Technical Skills:

• Strong understanding of CSV processes and validation lifecycle (IQ, OQ, PQ)
• Knowledge of regulatory standards such as GxP, FDA, and 21 CFR Part 11
• Experience with validation documentation and compliance processes
• Familiarity with quality management systems and risk assessment methodologies
• Understanding of IT systems and software validation

Soft Skills:

• Strong attention to detail and documentation accuracy
• Excellent analytical and problem-solving skills
• Effective communication and collaboration abilities

Certifications (Preferred):

• Certified Quality Engineer (CQE)
• GxP or validation-related certifications
• Regulatory compliance training certifications

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💼 Salary, Benefits & Career Growth

Average Market Salary (Estimated):
USD 85,000 – USD 115,000 per year (based on CSV Engineer roles in Florida, USA)

Compensation Structure:

• Annual salary or contract-based compensation
• Performance-based incentives (where applicable)

Benefits:

• Opportunity to work in regulated and high-impact industries
• Exposure to compliance-driven environments and validation frameworks
• Collaborative and quality-focused work culture

Career Growth & Professional Development:

• Advancement into Validation Lead, QA Manager, or Compliance Specialist roles
• Opportunities for certification in GxP, FDA compliance, and quality systems
• Hands-on training in validation methodologies and regulatory standards
• Continuous professional development in life sciences and technology compliance

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📝 Application Process

🔗 Application Process (Website):

Apply only through the official job link
Click Apply Now on the website

📧 HR Email for Application

📩 Send your updated CV directly to:

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Referred by: Rashid Naseem – Recrenza

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