Validation Team Lead

Eliquent Life Sciences, Inc • College Station, TX

19h

About The Position

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 [//eliquent.com].

We at ELIQUENT are looking for an experienced Validation Engineer to immediately join our ELIQUENT Engineering - Central team who will serve as a Validation Team Lead. The Validation Team Lead is responsible for leading a validation team while also assisting with the planning, execution, and documentation of equipment qualification activities in compliance with current Good Manufacturing Practices (cGMP), FDA, and global regulatory requirements. This role supports the qualification and lifecycle management of manufacturing, laboratory, and utility equipment used in pharmaceutical production.

We are seeking positions for both QC related equipment and Manufacturing related equipment.

Requirements

• Bachelor’s degree inEngineering, Chemistry, Biology, or a related scientific discipline
• At least7yearsof experience in equipment validation within a pharmaceutical, biotech, or regulated manufacturing environment
• Experience in project management
• Strong knowledge ofGMP regulationsandvalidationlifecycle requirements
• Experience withIQ/OQ/PQ execution and documentation
• Familiarity with FDA regulations, 21 CFR Parts210/211, and applicable guidance documents
• Ability to interpret engineering drawings, P&IDs, and equipment specifications
• Strong technical writing and documentation skills
• Experience with aseptic manufacturing, sterile fill-finish, or cleanroom environments
• Familiarity with automated equipment and CSV/CSA principles

Responsibilities

• Develop and execute equipment validation and qualification protocols, including URS, RA, IQ, OQ, and PQ
• Lead team of Validation Engineers on projects
• Ensure equipment qualification activitiescomply withcGMP, FDA, EMA, and ICH guidelines
• Support validation activities for manufacturing equipment, laboratory instruments, utilities, and automated systems
• Author, review, and approve validation documentation, including protocols, reports, deviations, and change controls
• Perform and document risk assessments (e.g., FMEA) todeterminevalidation scope and criticality
• Collaborate with Engineering, Manufacturing, Quality Assurance, and Automation teams to support equipment installation and commissioning
• Investigate validation deviations and execute corrective and preventive actions (CAPAs)
• Support validation activities related to new equipment installations, upgrades, and re-qualification
• Participate in internal and external audits and regulatory inspections
• Maintain validation documentationin accordance withdata integrity and document control requirements
• Provide validation support during technology transfer and process improvements
• Lead and execute CSV/CSA activities across thesystem lifecycle(concept through retirement)
• Develop and review validation deliverables including Validation Plans, URS, Risk Assessments, Test Scripts, and Summary Reports
• Apply risk-based CSA methodologies to determineappropriate validationrigor

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level