Senior Cleaning Validation Engineer & Data Integrity Lead

United Pharma; Kentucky; On-site; USD 120,000 - 150,000; Full time

Job summary

United Pharma in Lexington, KY, seeks a Senior CQV Engineer to support a high-impact Cleaning Validation and Data Integrity initiative at a pharmaceutical manufacturing facility. You will lead validation activities for manufacturing suites, process equipment, and laboratory systems within a regulated GMP environment.

The project includes development and execution of cleaning validation strategies, remediation planning, SOP creation, data integrity assessments, and cross-functional collaboration

Qualifications

• Bachelor's degree in engineering or related scientific field.
• 10+ years of CQV/Validation/Quality Engineering in regulated pharma or related industries.
• Demonstrated Cleaning Validation experience with protocol development and execution.
• Strong GMP knowledge and FDA expectations; ability to author/review lifecycle docs.
• Experience executing IQ/OQ/PQ for manufacturing/lab equipment.
• Proven ability to work independently with client leadership; excellent writing/communication.

Responsibilities

• Lead Cleaning Validation activities from planning through execution.
• Develop and execute cleaning validation protocols and reports.
• Design and support swab recovery studies and cleaning validation methods.
• Establish worst-case product/equipment groupings using risk-based approaches.
• Support protocol execution and field verification within manufacturing operations.
• Authorize and revise validation docs: Plans, Protocols, Reports, SOPs, Remediation Plans.
• Evaluate existing cleaning procedures and implement improvements.
• Perform Data Integrity assessments on lab systems/equipment.
• Identify compliance gaps and develop remediation strategies.
• Coordinate with Quality/Regulatory to align with GMP expectations.
• Support investigations, deviations, and change control activities.
• Provide technical leadership and mentorship to project team.

Skills

CQV

Validation

Quality Engineering

GMP knowledge

Technical writing

IQ/OQ/PQ

Independent work

Documentation

Education

Bachelor's Degree in Engineering, Chemistry, Life Sciences, Pharmaceutical Sciences, or related discipline

Tools

HPLC

Job description

United Pharma in Lexington, KY, seeks a Senior CQV Engineer to support a high-impact Cleaning Validation and Data Integrity initiative at a pharmaceutical manufacturing facility. You will lead validation activities for manufacturing suites, process equipment, and laboratory systems within a regulated GMP environment.

The project includes development and execution of cleaning validation strategies, remediation planning, SOP creation, data integrity assessments, and cross-functional collaboration