Senior CQV Engineer: Cleaning Validation & Data Integrity

Valspec; Philadelphia (Philadelphia County); On-site; USD 83,000 - 131,000; Part time

Benefits offered by this job

Premium medical coverage

401(k) with company match

Job summary

Valspec is seeking a Senior CQV Engineer to lead Cleaning Validation and Data Integrity initiatives at a pharmaceutical manufacturing facility in Lexington, Kentucky. This onsite contract role requires hands-on leadership across validation plans, risk assessments, and cross-functional collaboration with Quality, Engineering, Manufacturing, and Laboratory teams.

The ideal candidate has 10+ years in CQV/Validation within regulated pharma environments, strong GMP knowledge, and proven ability to

Qualifications

• 10+ years of CQV, Validation, or Quality Engineering experience in regulated pharma environments
• Demonstrated Cleaning Validation 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 with client leadership
• Excellent technical writing and communication skills

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, Risk Assessments, 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 GMP alignment
• Support investigations, deviations, and change control activities related to validation programs
• Provide technical leadership and mentorship to project teams

Skills

CQV expertise

Validation

Technical writing

GMP knowledge

Client engagement

Education

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

Tools

IQ/OQ/PQ execution

Data Integrity tools

Job description

Valspec is seeking a Senior CQV Engineer to lead Cleaning Validation and Data Integrity initiatives at a pharmaceutical manufacturing facility in Lexington, Kentucky. This onsite contract role requires hands-on leadership across validation plans, risk assessments, and cross-functional collaboration with Quality, Engineering, Manufacturing, and Laboratory teams.

The ideal candidate has 10+ years in CQV/Validation within regulated pharma environments, strong GMP knowledge, and proven ability to