Consultant 1

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 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 (IQ/OQ/PQ/FAT/SAT), and Reports
  • User Requirements Specifications (URS), Functional Specifications (FS), and Traceability Matrices
  • Risk assessments and Data Integrity assessments
• 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.

Consultant Levels:

Consultant I (Entry-Level / Junior) 

• Experience: 0–3 years CSV or validation experience in GMP environment
• Responsibilities: Execute protocols, perform testing, collect evidence, assist with documentation, learn regulatory requirements under supervision.
  

Consultant II (Mid-Level) 

• Experience: 3–6 years CSV experience, strong working knowledge of FDA/EU regulations, independent execution of validation projects.
• Responsibilities: Lead small projects or system validations, author protocols and reports, manage deviations, interface with clients and auditors, mentor Consultant I.
  

Consultant III (Senior-Level) 

• Experience: 6–10+ years CSV or validation leadership experience, expertise in multiple system types (LIMS, MES, SCADA, ERP, Lab/Automation Equipment).
• Responsibilities: Lead complex CSV programs, oversee multiple system validations, manage validation teams, develop strategies, ensure audit readiness, and advise on compliance.

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:

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.