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 CQV Engineer with hands-on experience in Computer System Validation (CSV) activities specific to equipment systems. The ideal candidate will have a strong foundation in equipment qualification (IQ/OQ/PQ) and a working knowledge of 21 CFR Part 11 compliance, including the development of associated deliverables such as Admin SOPs, Backup & Restore procedures, and Design Specifications.
Key Responsibilities:
- Lead and/or support the commissioning and qualification (CQV) of GMP equipment and associated computerized systems.
- Review and/or author validation documentation: User Requirements Specifications (URS), Functional Requirements (FRS), Design Specifications (DS), Traceability Matrices (RTM), IQ/OQ/PQ protocols, and Summary Reports.
- Assist in ensuring 21 CFR Part 11 compliance for equipment with electronic records and signatures.
- Support development and review of Admin SOPs, Backup & Restore procedures, Audit Trail assessments, and system access controls.
- Participate in design review, risk assessment (RA), and impact assessment activities.
- Collaborate with cross-functional teams including QA, IT, Manufacturing, and Engineering to align validation strategies.
- Support deviations, CAPAs, and change controls related to equipment and CSV.
- Ensure all validation activities are performed in compliance with internal procedures, GAMP 5, and regulatory expectations.
Salary Range: 120k-135k
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 6-8 years of experience in CQV roles within GMP-regulated environments.
- Familiarity with equipment CSV principles, especially regarding data integrity and Part 11.
- Strong understanding of GAMP 5, Annex 11, and relevant FDA guidance.
- Proficiency in authoring or reviewing system Design Specs, Admin SOPs, and validation protocols.
- Comfortable working with automated systems, PLCs, HMIs, and SCADA integration.
- Excellent documentation practices and communication skills.
- Experience supporting equipment-based systems such as bioreactors, chromatography skids, autoclaves, or controlled environmental units.
- Exposure to CSV testing tools or system configuration audits.
- Experience working in a project-based consulting environment is a plus.
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.