CSV Engineer

Eliquent Life Sciences, Inc • Costa Mesa, CA

89d

About The Position

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. We are seeking a motivated Computerized Systems Validation (CSV) Engineer to join our team. This role will focus on supporting validation activities for GMP manufacturing equipment, laboratory systems, and IT systems in regulated life sciences environments. The CSV Engineer will author validation deliverables—including protocols, reports, and SOPs—ensuring compliance with FDA, EMA, and global regulatory expectations.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
• Direct experience with GxP equipment, IT systems, or manufacturing automation systems.
• Working knowledge of FDA and cGMP regulations and documentation practices.
• Familiarity with GAMP 5 guidance.
• Knowledge of 21 CFR Part 11 and Annex 11.
• Understanding of computer system validation methodologies.
• Familiarity with risk-based validation execution strategies.
• Strong technical writing skills with attention to detail.

Nice To Haves

• Experience authoring SOPs for laboratory or manufacturing equipment.
• Familiarity with LIMS, MES, SCADA, or laboratory instrumentation.
• Prior exposure to audits or regulatory inspections.
• Ability to manage multiple projects under tight deadlines.

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.

Benefits

• Attractive salary and comprehensive benefits package for full-time and part-time employees.
• Health, dental, vision, and life insurance.
• 401(k) plan with employer match.
• Generous paid time off policy.
• Opportunities for professional growth and advancement.
• Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree