CSV Engineer

ELIQUENT Life Sciences; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

ELIQUENT Life Sciences in Madison, WI, is seeking a Computerized Systems Validation (CSV) Engineer to support FDA and EMA regulatory compliance in GMP environments. You will author validation deliverables and collaborate with Quality, Engineering, and IT teams to ensure systems meet regulatory expectations.

The role emphasizes risk-based validation, IQ/OQ execution, and generation of Validation Summary Reports, with opportunities to contribute to validation strategies and inspection readiness.

Qualifications

• Bachelor’s degree required in a relevant field.
• 5+ years of computerized systems validation experience in pharma/biotech/l life sciences.
• Experience with GMP environments and validated systems.

Responsibilities

• Develop and maintain Design Specifications (DS) for computerized and automated systems.
• Author and execute IQ and OQ protocols.
• Generate and review validation reports and VSRs.
• Write and maintain SOPs for validated systems and equipment.
• Support CSV activities for IT and manufacturing automation.
• Apply risk-based validation aligned with regulatory guidance.
• Collaborate with Quality, Engineering, and IT to align deliverables with compliance.
• Contribute to inspection readiness through validated documentation.

Skills

Regulatory compliance

Technical writing

Quality systems

Cross-functional collaboration

Education

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

Tools

FDA 21 CFR Part 11

GAMP 5

Data Integrity (ALCOA+)

Job description

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

We are seeking a Computerized Systems Validation (CSV) Engineer experience to join our team. This role supports compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, and Good Documentation Practices (GDP). The CSV Engineer will author validation deliverables—including protocols, reports, and SOPs—ensuring compliance with FDA, EMA, and global regulatory expectations.

Key Responsibilities:

• Develop and maintain Design Specifications (DS) for computerized and automated systems.
• Author and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Generate and review validation reports and Validation Summary Reports (VSRs).
• Author and maintain Standard Operating Procedures (SOPs) for validated systems and equipment.
• Support implementation of CSV activities for IT and manufacturing automation systems in GMP environments.
• Apply risk-based validation approaches in alignment with industry standards and regulatory guidance.
• Partner with Quality, Engineering, and IT teams to align validation deliverables with compliance and business needs.
• Contribute to inspection readiness by ensuring validation documentation meets regulatory expectations.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.

Working knowledge of:

• FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSV lifecycle methodologies, Data Integrity principles (ALCOA+)
• Strong technical writing skills with attention to detail.