Senior Validation Lead - GMP & CSV Specialist

Creative Solutions Services, LLC

Cincinnati (OH)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Creative Solutions Services, LLC is seeking 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, ensuring FDA/EMA compliance.

The role requires 5+ years in GMP validation, strong technical writing, and collaboration with QA, Manufacturing, and Regulatory teams.

Qualifications

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
5+ years of validation experience in a GMP-regulated environment.
Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
Excellent technical writing and documentation skills.
Knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, CSV, Risk Assessments, Change Control and CAPA.

Responsibilities

Lead validation lifecycle activities including DQ, IQ, OQ, PQ.
Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
Execute equipment, process, cleaning, utility, facility, and CSV activities.
Support C&A activities for new equipment and manufacturing systems.
Manage deviations, investigations, CAPAs, and change controls related to validation.
Develop and maintain Validation Master Plans (VMPs).
Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
Support regulatory inspections and audits.
Collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory teams.
Mentor junior validation engineers and specialists.