Validation Consultant - Periodic Review

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 skilled and detail-oriented Validation Engineer with 4–10 years of experience to support equipment/system qualification as part of periodic review in a GMP-compliant facility. The ideal candidate will be responsible for executing periodic reviews, supporting qualification efforts across lab and manufacturing systems, and ensuring compliance with applicable regulatory and internal quality standards. This role plays a critical part in maintaining the validated state of equipment and systems and supporting continuous improvement initiatives. 

• Generate/execute Periodic Reviews and Re-qualifications of equipment/systems/ facility according to the schedule in the Validation Master Plan  

• Drive on-time closure of Periodic Reviews through proactive project management and stakeholder coordination.   

• Review of calibration and maintenance activities, quality records, lifecycle document and procedure changes to assess impact on validated state. 

• Utilize problem solving skills and provide guidance to determine root cause and corrective actions. 

• Qualification support  

• Generate and execute Validation Protocols and write final reports for systems such as CTU, QC lab instruments (Flow Cytometer, PCR, Cell Counter, ELISA Reader, Microbial Analyzer etc.), and benchtop systems (FIT, cell isolation, cell separation etc.) 

• Support utilities (LN2, CO2 and Purified Water) qualifications, as needed. 

• Support Cleanroom Validation Studies and Airflow Visualization Studies, as needed.  

• Documentation  

• Authoring, including revisions, of Qualification Protocols and Reports as needed within Veeva Vault.  

• Routing Documents through Veeva Vault for review and approval workflows.  

• Execution of protocols will be performed manually on paper and uploaded to Veeva Vault. Demonstrate proper GDP for paper records.  

Salary Range: 100k-120k

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field (e.g., Mechanical, Chemical, Biomedical Engineering, Biology, or Chemistry) required. 
• 4–10 years of experience in equipment/system validation or facility/utility qualification in a GMP-regulated environment (biotech, pharmaceutical, or cell therapy industry preferred). 
• Hands-on experience performing Periodic Reviews, equipment/system re-qualifications, and updating/generating validation lifecycle documentation. 
• Experience with Quality Assurance, Deviation Management, and CAPA systems. 
• Proficient in writing and executing Validation Protocols (IQ/OQ/PQ) and Final Reports for lab equipment, utilities, and cleanroom environments. 
• Familiarity with validation of lab instruments (e.g., Flow Cytometers, PCR, ELISA Readers, Cell Counters) and benchtop systems used in manufacturing or QC labs. 
• Knowledge of critical utility systems (e.g., LN₂, CO₂, Purified Water) and associated qualification practices. 
• Experience with cleanroom qualification, including Airflow Visualization Studies, particle count monitoring, and pressure differential assessments. 
• Solid understanding of GMP, FDA, ICH, and EU Annex 15 regulations and guidelines related to validation and qualification. 
• Strong Good Documentation Practices (GDP) for both paper-based and electronic records. 
• Proficient in using Veeva Vault for document authoring, routing, and approval  
• Excellent written and verbal communication skills to collaborate with cross-functional teams and provide updates to stakeholders. 
• Self-starter with the ability to manage multiple tasks, prioritize, and adapt in a dynamic and fast-paced environment. 
• Detail-oriented and highly organized with a strong sense of ownership and accountability. 

 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.