Senior Cleaning Validation & Data Integrity Expert in GMP

United Pharma

Kentucky

On-site

USD 130,000 - 170,000

Full time

5 days ago

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Job summary

United Pharma seeks a Senior CQV Engineer to lead Cleaning Validation and Data Integrity initiatives at a pharmaceutical manufacturing site in Kentucky. You will oversee validation of suites, equipment, and laboratory systems in a GMP environment, developing strategies and documents while collaborating across Quality, Manufacturing, and Engineering teams.

The ideal candidate has 10+ years in CQV/Validation within regulated pharma settings, strong technical writing skills, and proven ability to

Qualifications

Bachelor-level degree in a relevant scientific or engineering field.
10+ years CQV/Validation/Quality Engineering in regulated pharma/biotech.
Experience developing and executing cleaning validation strategies.
Strong understanding of current GMP and FDA expectations.
Ability to author and review lifecycle validation documents.
Experience IQ/OQ/PQ activities for manufacturing/lab equipment.

Responsibilities

Lead Cleaning Validation from planning through execution.
Develop and execute cleaning validation protocols and reports.
Design and support swab recovery studies and validation methods.
Establish worst-case product/equipment groupings using risk-based approaches.
Support protocol execution and field verification within operations.
Author and revise Validation Plans, Protocols, Summary Reports, SOPs.
Remediation plans and improvements to existing procedures.
Conduct Data Integrity assessments on laboratory systems and equipment.
Identify compliance gaps and drive corrective actions and remediation strategies.
Collaborate with Quality and Regulatory to align with GMP expectations.
Support investigations, deviations, and change controls for validation programs.
Provide technical leadership and mentorship to project teams.