Senior Validation Lead: GMP Compliance & CQV Expert

Creative Solutions Services, LLC

Richmond (VA)

On-site

USD 115,000 - 175,000

Full time

14 days+

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Job summary

Creative Solutions Services, LLC in Richmond, Virginia, seeks an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems in alignment with FDA, EMA, and cGMP.

The role requires strong expertise in IQ/OQ/PQ, CSV, risk assessments, change control, CAPA, and collaboration with QA,

Qualifications

Bachelor's degree in a field related to engineering, life sciences, or chemistry.
5+ years of validation experience in a GMP environment.
Proven expertise in IQ/OQ/PQ, CSV, and risk assessments.
Experience with FDA/EMA guidelines and cGMP requirements.
Strong technical writing and documentation skills.

Responsibilities

Lead validation lifecycle activities (DQ/IQ/OQ/PQ) and related documentation.
Execute validation for equipment, processes, cleaning, utilities, and computer systems.
Support deviation investigations, CAPAs, and change controls.
Collaborate with QA, Manufacturing, Engineering, Automation, and Regulatory teams.
Mentor junior validation engineers and specialists.