Eliquent Life Sciences, Inc

Compensation

Full 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. 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: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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: • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline. • 3–7 years of experience in validation, quality, or compliance within a GMP-regulated industry. • Strong organizational skills with attention to detail and ability to manage multiple priorities. • Effective communication and technical writing skills for documentation and cross-functional collaboration. Preferred / Nice to Have: • Familiarity with Computer System Validation (CSV) principles and documentation. • Working knowledge of GAMP 5 guidance for computerized systems. • Understanding of 21 CFR Part 11 requirements for electronic records and signatures. • Experience using electronic quality management systems (e.g., MasterControl, TrackWise, Veeva). • Exposure to manufacturing, laboratory, or facility/utility systems within a GMP environment. 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.