Sr. Validation Engineer

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

Senior CQV Engineer to support a high-impact Cleaning Validation and Data Integrity initiative at a pharmaceutical manufacturing facility in Lexington, Kentucky.

This consultant will lead validation activities supporting 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 with Engineering, Quality, Manufacturing, and Laboratory teams.

The facility manufactures veterinary pharmaceutical products in powder, tablet, and granule dosage forms and operates multiple manufacturing suites as well as quality control laboratory operations utilizing HPLC, stability, incubation, dissolution, and analytical testing equipment.

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 and equipment groupings using scientific and risk-based approaches
• Support protocol execution and field verification activities within manufacturing operations
• Author and revise validation documentation including:
• Validation Plans
• Protocols
• Summary Reports
• SOPs
• Remediation Plans
• Evaluate existing cleaning procedures and implement improvements where necessary
• Perform Data Integrity assessments on laboratory systems and equipment
• Identify compliance gaps and develop corrective actions and remediation strategies
• Partner with Quality and Regulatory stakeholders to ensure alignment with current GMP expectations
• Support investigations, deviations, and change control activities related to validation programs
• Provide technical leadership and mentorship to project team members as required

Required Qualifications

• Bachelor's Degree in Engineering, Chemistry, Life Sciences, Pharmaceutical Sciences, or related discipline
• 10+ years of CQV, Validation, or Quality Engineering experience within regulated pharmaceutical, biotech, medical device, or animal health manufacturing environments
• Demonstrated Cleaning Validation experience including protocol development and execution
• Strong understanding of current GMP regulations and FDA expectations
• Experience authoring and reviewing validation lifecycle documentation
• Experience executing IQ/OQ/PQ activities for manufacturing and laboratory equipment
• Proven ability to work independently and interact directly with client leadership
• Excellent technical writing and communication skills

Preferred Qualifications

• Experience supporting powder, blending, tableting, filling, packaging, or related pharmaceutical operations
• Swab method development and recovery study experience
• Data Integrity assessment and remediation experience
• Familiarity with HPLC, dissolution, stability, incubation, and analytical laboratory systems
• Experience supporting FDA inspections and audit readiness initiatives
• Previous consulting experience within pharmaceutical manufacturing environments