ELIQUENT Life Sciences
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. 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 Reports Execute validation testing and document results in compliance with GMP/GLP standards Support ongoing system lifecycle management: periodic reviews, requalification, and change control Collaborate 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 SOPs Qualifications Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (required) Knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11 Strong documentation, communication, and organizational skills Ability to work independently and within cross-functional teams Consulting mindset with adaptability to dynamic project needs Benefits Competitive Compensation: Attractive salary and comprehensive benefits package 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. Base pay range: $42.00/hr - $66.00/hr
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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. 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 Reports Execute validation testing and document results in compliance with GMP/GLP standards Support ongoing system lifecycle management: periodic reviews, requalification, and change control Collaborate 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 SOPs Qualifications Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (required) Knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11 Strong documentation, communication, and organizational skills Ability to work independently and within cross-functional teams Consulting mindset with adaptability to dynamic project needs Benefits Competitive Compensation: Attractive salary and comprehensive benefits package 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. Base pay range: $42.00/hr - $66.00/hr
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