CSV Engineer

Job DescriptionELIQUENT 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.We are seeking CSV Consultants at multiple levels (Consultant I, Consultant II, Consultant III) to support validation and compliance activities for computerized systems in a regulated GMP environment. These roles will involve executing validation deliverables, ensuring data integrity, and maintaining inspection readiness across manufacturing, laboratory, and IT systems.Responsibilities (all levels):Author and/or review CSV documentation, including Validation Plans, Protocols, and ReportsExecute validation testing and document results in compliance with GMP/GLP standardsSupport ongoing system lifecycle management: periodic reviews, requalification, and change controlCollaborate with cross-functional teams (Quality, IT, Engineering, Operations, Automation)Provide support during audits and inspections to ensure systems meet regulatory expectations (FDA, EMA, etc.)Ensure compliance with relevant guidelines: GAMP 5, 21 CFR Part 11, EU Annex 11, and company SOPsQualificationsBachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (required)Knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11Strong documentation, communication, and organizational skillsAbility to work independently and within cross-functional teamsConsulting mindset with adaptability to dynamic project needsBenefitsCompetitive Compensation: Attractive salary and comprehensive benefits packageCareer Development: Opportunities for professional growth and advancement within a supportive and innovative environmentWork-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balanceELIQUENT Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.Base pay range: $42.00/hr - $66.00/hr #J-18808-Ljbffr

Created: 2025-10-06