CSV Engineer

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 will focus on supporting laboratory 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.


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.
• 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries.
• Working knowledge of:
  • FDA and cGMP regulations and documentation practices
  • Computer system validation methodologies
  • Strong technical writing skills with attention to detail.
• Direct experience with Evolve System preferred.

BENEFITS:

What We Offer:

Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.

Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.

Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.