Lead Equipment Validation Engineer

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Hikma Pharmaceuticals in Bedford, OH seeks an Equipment Validation Engineer III to lead qualification activities for sterile manufacturing equipment and support lifecycle management. You will guide IQ/OQ/PQ efforts, collaborate with Operations, Engineering, Quality, and Regulatory teams, and ensure compliant validation practices across projects.

The role emphasizes risk-based validation strategies, documentation rigor, and continuous process improvement, with opportunities to mentor junior

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Mathematics, or related technical discipline.
• Minimum of 4 years of validation, engineering, pharmaceutical manufacturing, or related industry experience.
• Working knowledge of cGMP regulations and validation principles within regulated manufacturing environments.
• Strong technical writing skills with experience authoring validation protocols and reports.
• Demonstrated ability to independently manage technical projects and collaborate with cross-functional teams.
• Strong verbal and written communication skills.

Responsibilities

• Lead equipment qualification activities, including IQ, OQ, and PQ for new and existing manufacturing equipment.
• Perform change assessments and lead requalification activities in support of equipment modifications, process changes, and lifecycle management.
• Author, execute, and review validation impact assessments, protocols, test scripts, summary reports, periodic review reports and supporting documentation.
• Ensure validation activities are executed in accordance with applicable cGMP regulations, company procedures, and industry best practices.
• Serve as validation lead for capital projects, equipment implementation efforts, and cross-functional initiatives.
• Partner with Engineering during equipment design, installation, commissioning, startup, and qualification phases.
• Coordinate qualification activities across Operations, Quality Control, Quality Assurance, Engineering, Maintenance, and Manufacturing Science teams.
• Manage multiple validation projects simultaneously while maintaining project timelines and priorities.
• Support manufacturing investigations, deviation assessments, root cause analyses, and CAPA implementation activities related to validated systems.
• Participate in risk assessments and develop scientifically sound validation approaches.
• Maintain validation documentation in a state of audit readiness.
• Support internal audits, client/customer audits, and regulatory inspections, including FDA and global regulatory agencies.
• Contribute validation documentation and technical justifications for regulatory submissions when required.
• Mentor junior validation engineers and provide guidance on validation methodologies, documentation practices, and compliance expectations.

Skills

Technical writing

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering or related field

Tools

GAMP 5

Job description

Hikma Pharmaceuticals in Bedford, OH seeks an Equipment Validation Engineer III to lead qualification activities for sterile manufacturing equipment and support lifecycle management. You will guide IQ/OQ/PQ efforts, collaborate with Operations, Engineering, Quality, and Regulatory teams, and ensure compliant validation practices across projects.

The role emphasizes risk-based validation strategies, documentation rigor, and continuous process improvement, with opportunities to mentor junior