Senior Validation Engineer – Sterile Pharmaceutical Equipment

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 90,000 - 125,000; Full time

Job summary

Hikma Pharmaceuticals seeks an Equipment Validation Engineer III to lead qualification activities for sterile manufacturing equipment. You will drive IQ/OQ/PQ, perform change assessments, and ensure compliance with cGMP while coordinating with Operations, Engineering, Quality, and Regulatory functions.

The role emphasizes technical leadership on validation projects, risk-based approaches, and lifecycle management, with exposure to capital projects and regulatory inspections across

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum of 4 years of validation, engineering, or related experience.
• Working knowledge of cGMP regulations and validation principles.
• Strong technical writing and collaboration across cross-functional teams.

Responsibilities

• Lead IQ, OQ, and PQ for new and existing manufacturing equipment.
• Coordinate change assessments and lead requalification activities.
• Author, execute, and review validation documents and reports.
• Maintain audit-ready validation documentation and support regulatory inspections.
• Mentor junior validation engineers and collaborate with cross-functional teams.

Skills

Technical writing

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in Engineering

Tools

GAMP 5 familiarity

Job description

Hikma Pharmaceuticals seeks an Equipment Validation Engineer III to lead qualification activities for sterile manufacturing equipment. You will drive IQ/OQ/PQ, perform change assessments, and ensure compliance with cGMP while coordinating with Operations, Engineering, Quality, and Regulatory functions.

The role emphasizes technical leadership on validation projects, risk-based approaches, and lifecycle management, with exposure to capital projects and regulatory inspections across