Cleaning Validation - SME

United Pharma; Kentucky; On-site; USD 130,000 - 170,000; Full time

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.

Skills

CQV/Validation

GMP compliance

Technical writing

Client leadership

Data integrity

Education

Bachelor's Degree in Engineering/Chemistry/Life Sciences/Pharmaceutical Sciences

Tools

HPLC

IQ/OQ/PQ

Dissolution testing

Job description

Senior CQV Engineer to support a high-impact Cleaning Validation and Data Integrity initiative at a pharmaceutical manufacturing facility

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

Ideal Candidate

We are seeking a hands-on consultant who can operate as both a technical subject matter expert and a project leader. The ideal candidate is comfortable working directly with Quality, Manufacturing, Engineering, and Laboratory stakeholders while driving validation deliverables independently.

Candidates with strong CQV backgrounds from biotech facilities are encouraged to apply, particularly those who have supported equipment qualification, validation remediation programs, laboratory systems, and cleaning validation initiatives.