Validation and Compliance 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.

Overview

The Validation & Compliance Specialist will support the execution and maintenance of validation, quality, and compliance deliverables across facility, utility, equipment, and computerized systems. This role ensures that documentation and activities meet regulatory expectations and internal quality standards while supporting CAPA commitments and ongoing site validation programs.

Key Responsibilities

• Validation and Documentation Support
• Author, review, and update controlled documents including validation plans, protocols, reports, and procedures.
• Ensure all documentation aligns with current GMP standards and internal quality requirements.
• Maintain lifecycle traceability for validation deliverables and support document archival activities.
• Assessments and Periodic Reviews
• Conduct compliance and system assessments to evaluate functionality, data integrity, and adherence to validation requirements.
• Perform and document periodic reviews of qualified systems to verify continued state of control.
• Identify and communicate gaps or improvement opportunities in system management or documentation.
• Qualification and Testing Activities
• Support or execute qualification protocols (IQ / OQ / PQ) for manufacturing, laboratory, and utility systems.
• Review calibration, maintenance, and environmental monitoring records for accuracy and completeness.
• Participate in annual testing or requalification efforts such as environmental mapping and equipment verifications.
• CAPA, Deviation, and Change Control Execution
• Support investigations for deviations and data or system integrity issues.
• Draft or execute CAPA action plans and verify effectiveness of implemented corrective actions.
• Evaluate change controls for potential validation or documentation impacts.
• Reporting and Continuous Improvement
• Compile validation and compliance reports on a scheduled basis and maintain associated records.
• Support continuous improvement initiatives to streamline validation documentation and review processes.
• Collaborate cross-functionally with Quality, Facilities, Engineering, and IT teams to ensure alignment of validation and compliance efforts.

Qualifications

Preferred / Nice to Have

Benefits

What We Offer :

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

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