Lead Equipment Validation Engineer — High-Impact Pharma

Hikma; Bedford (OH); On-site; USD 95,000 - 125,000; Full time

Job summary

Hikma is seeking an Equipment Validation Engineer to lead IQ/OQ/PQ activities for sterile manufacturing equipment, ensuring cGMP compliance across lifecycle management. You will partner with Engineering, Quality, Operations, and Regulatory teams to drive qualification strategies and capital projects.

The role emphasizes risk-based validation, documentation excellence, and mentorship of junior engineers, with exposure to regulatory inspections and continuous process improvements in a

Qualifications

• Bachelor's degree in engineering, life sciences, chemistry, biology, pharmaceutical sciences, mathematics, or related field.
• Minimum of 4 years of validation/engineering/pharmaceutical manufacturing experience.
• Working knowledge of cGMP regulations and validation principles in regulated environments.
• Strong technical writing skills with experience authoring validation protocols and reports.

Responsibilities

• Lead equipment qualification activities (IQ/OQ/PQ) for new and existing manufacturing equipment.
• Perform change assessments and lead requalification for modifications and lifecycle management.
• Author, execute, and review validation impact assessments, protocols, scripts, reports, and summaries.
• Ensure validation activities meet cGMP, procedures, and industry best practices.
• Serve as validation lead for capital projects and cross-functional initiatives.
• Coordinate qualification activities across Operations, Quality, Engineering, and Maintenance.
• Provide technical guidance on equipment lifecycle management and continuous improvement.
• Support regulatory audits and inspections with validated documentation.

Skills

Technical writing

Cross-functional collaboration

Project management

Risk-based validation

GxP compliance awareness

Education

Bachelor's degree in Engineering/Life Sciences/Pharma

4+ years experience in validation/engineering

Strong technical writing

Tools

IQ/OQ/PQ protocols

GAMP 5

CAPA systems

Job description

Hikma is seeking an Equipment Validation Engineer to lead IQ/OQ/PQ activities for sterile manufacturing equipment, ensuring cGMP compliance across lifecycle management. You will partner with Engineering, Quality, Operations, and Regulatory teams to drive qualification strategies and capital projects.

The role emphasizes risk-based validation, documentation excellence, and mentorship of junior engineers, with exposure to regulatory inspections and continuous process improvements in a