ELIQUENT Life Sciences · 11 hours ago
Validation Team Lead
College Station, TX, US
Full-time, Part-time
Onsite
Senior Level
$70/hr - $75/hr
7+ years expELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies. The Validation Team Lead is responsible for leading a validation team and assisting with the planning, execution, and documentation of equipment qualification activities in compliance with regulatory requirements.
ConsultingMedical DeviceProfessional Services
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 activities comply with cGMP, 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) to determine validation 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 documentation in accordance with data integrity and document control requirements
Provide validation support during technology transfer and process improvements
Lead and execute CSV/CSA activities across the system 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 determine appropriate validation rigor
Qualification
Required
Bachelor's degree in Engineering, Chemistry, Biology, or a related scientific discipline
At least 7 years of experience in equipment validation within a pharmaceutical, biotech, or regulated manufacturing environment
Experience in project management
Strong knowledge of GMP regulations and validation lifecycle requirements
Experience with IQ/OQ/PQ execution and documentation
Familiarity with FDA regulations, 21 CFR Parts 210/211, 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
Benefits
Health, dental, vision, and life insurance
A 401(k) plan with employer match
A generous paid time off policy
Additional perks
Company
ELIQUENT Life Sciences
ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.
501-1000 employees
H1B Sponsorship
ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (3)
Funding
Current Stage
Late StageLeadership Team
Stephen Purtell
Chief Financial Officer
Rob Wojciechowski
Chief Operating Officer
Recent News
2025-05-08
globallegalchronicle.com
2025-04-07
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