CQV Engineer

United Pharma; Kentucky; On-site; USD 120,000 - 160,000; Full time

Job summary

United Pharma seeks a Senior CQV Engineer to lead cleaning validation and data integrity programs within a GMP-regulated pharmaceutical manufacturing facility. You will provide technical leadership across validation activities, collaborating with Engineering, Quality, Manufacturing, and Laboratory teams.

The role requires hands-on cleaning validation experience, IQ/OQ/PQ lifecycle expertise, and strong GMP/FDA knowledge, complemented by excellent writing and cross-functional collaboration skills

Qualifications

• Bachelor's degree in Engineering, Chemistry, Life Sciences, Pharmaceutical Sciences, or related field.
• 10+ years of CQV, Validation, or Quality Engineering experience in a regulated pharmaceutical/biotech/medical device environment.
• Strong hands-on Cleaning Validation experience, including protocol development and execution.
• Strong understanding of GMP regulations and FDA expectations.
• Experience with validation lifecycle documentation and IQ/OQ/PQ activities.
• Excellent technical writing, communication, and problem-solving skills.
• Ability to work independently and interact with client leadership and cross-functional teams.

Responsibilities

• Lead Cleaning Validation activities from planning through execution and closeout.
• Develop and execute cleaning validation protocols, reports, and strategies.
• Support swab recovery studies, cleaning methods, and sampling activities.
• Establish scientifically justified worst-case product and equipment groupings using risk-based approaches.
• Perform field verification and provide hands-on support during manufacturing activities.
• Author and review validation plans, risk assessments, protocols, summary reports, SOPs, and remediation plans.
• Evaluate existing cleaning procedures and recommend process improvements.
• Conduct Data Integrity assessments for laboratory systems and equipment.
• Identify compliance gaps and support corrective actions and remediation plans.
• Support IQ/OQ/PQ, deviations, investigations, and change controls related to validation activities.

Skills

Cleaning Validation

CQV

GMP

Regulatory Knowledge

Technical Writing

Cross-functional Collaboration

Education

Bachelor's degree (Engineering/Science)

Job description

We are seeking a Senior CQV Engineer to support a major Cleaning Validation and Data Integrity program within a GMP-regulated pharmaceutical manufacturing facility. The role will provide technical leadership across manufacturing and laboratory validation activities, working closely with Engineering, Quality, Manufacturing, and Laboratory teams.

Key Responsibilities:

• Lead Cleaning Validation activities from planning through execution and closeout.
• Develop and execute cleaning validation protocols, reports, and strategies.
• Support swab recovery studies, cleaning methods, and sampling activities.
• Establish scientifically justified worst-case product and equipment groupings using risk-based approaches.
• Perform field verification and provide hands-on support during manufacturing activities.
• Author and review validation plans, risk assessments, protocols, summary reports, SOPs, and remediation plans.
• Evaluate existing cleaning procedures and recommend process improvements.
• Conduct Data Integrity assessments for laboratory systems and equipment.
• Identify compliance gaps and support corrective actions and remediation plans.
• Support IQ/OQ/PQ, deviations, investigations, and change controls related to validation activities.

Required Qualifications:

• Bachelor's degree in Engineering, Chemistry, Life Sciences, Pharmaceutical Sciences, or related field.
• 10+ years of CQV, Validation, or Quality Engineering experience in a regulated pharmaceutical, biotech, medical device, or animal health environment.
• Strong hands-on Cleaning Validation experience, including protocol development and execution.
• Strong understanding of GMP regulations and FDA expectations.
• Experience with validation lifecycle documentation and IQ/OQ/PQ activities.
• Excellent technical writing, communication, and problem-solving skills.
• Ability to work independently and interact directly with client leadership and cross-functional teams.