Senior Equipment Validation Engineer - Sterile Pharma

Hikma; Bedford (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Hikma in Bedford, Ohio is seeking an Equipment Validation Engineer III to lead IQ/OQ/PQ activities for sterile manufacturing equipment. You will manage lifecycle qualification and support investigations, ensuring cGMP compliance across cross-functional teams.

The role offers exposure to capital projects, equipment implementation, and regulatory inspections, with mentoring of junior engineers and opportunities to influence site validation strategy.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum 4 years of validation/engineering experience in regulated manufacturing.
• Working knowledge of cGMP regulations and validation principles.
• Strong technical writing skills with experience authoring validation documentation.

Responsibilities

• Lead IQ/OQ/PQ activities for new and existing equipment.
• Perform change assessments and requalification for equipment modifications.
• Author/execute validation impact assessments, protocols, reports, and summaries.
• Ensure validation activities comply with cGMPs and company procedures.
• Mentor junior engineers and coordinate cross-functional validation projects.

Skills

Equipment validation

cGMP/regulatory

Technical writing

Project leadership

Cross-functional teams

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ

GAMP 5

Job description

Hikma in Bedford, Ohio is seeking an Equipment Validation Engineer III to lead IQ/OQ/PQ activities for sterile manufacturing equipment. You will manage lifecycle qualification and support investigations, ensuring cGMP compliance across cross-functional teams.

The role offers exposure to capital projects, equipment implementation, and regulatory inspections, with mentoring of junior engineers and opportunities to influence site validation strategy.