Senior CQV Engineer – Cleaning Validation & Data Integrity

Valspec; Makkah Region; On-site; SAR 450,000 - 675,000; Full time

Benefits offered by this job

Travel and Per Diem

Onsite at Lexington, KY

Job summary

Valspec is seeking a Senior CQV Engineer to support Cleaning Validation and Data Integrity initiatives at a pharmaceutical manufacturing facility in Lexington, Kentucky. The consultant will lead validation activities for manufacturing suites, process equipment, and laboratory systems within a regulated GMP environment.

The role involves developing and executing cleaning validation strategies, remediation planning, SOP creation, data integrity assessments, and cross-functional collaboration with

Qualifications

• Bachelor's degree in engineering, chemistry, life sciences or related field.
• 10+ years in CQV/Validation within regulated pharmaceutical environments.
• Cleaning validation protocol development and execution experience.
• Strong GMP knowledge and FDA expectations.
• Ability to author and review lifecycle validation documents.
• Experience executing IQ/OQ/PQ for equipment.
• Independent worker with client-facing interaction and strong writing skills.

Responsibilities

• Lead Cleaning Validation activities from planning through execution.
• Develop and execute cleaning validation protocols and reports.
• Design swab recovery studies and validation methods.
• Establish worst-case groupings using scientific risk-based approaches.
• Author validation plans, risk assessments, protocols, summaries, and SOPs.
• Perform data integrity assessments on lab systems and equipment.
• Support investigations, deviations, and change control related to validation.

Skills

Cleaning Validation

Data Integrity

Technical Leadership

Documentation Writing

Education

Bachelor's Degree in Engineering or Science

Tools

HPLC

Analytical Testing Equipment

IQ/OQ/PQ

Job description

Valspec is seeking a Senior CQV Engineer to support Cleaning Validation and Data Integrity initiatives at a pharmaceutical manufacturing facility in Lexington, Kentucky. The consultant will lead validation activities for manufacturing suites, process equipment, and laboratory systems within a regulated GMP environment.

The role involves developing and executing cleaning validation strategies, remediation planning, SOP creation, data integrity assessments, and cross-functional collaboration with