GMP Equipment Qualification Engineer (IQ/OQ & Validation)

Olon USA; Ohio; On-site; USD 85,000 - 110,000; Full time

Job summary

Olon USA in Concord, OH, is seeking an Equipment Qualification Engineer with 3–5 years of validation or qualification experience to manage GMP production equipment qualification lifecycle. The role focuses on IQ/OQ executions for small molecule processing equipment and collaboration with Maintenance, QA, Engineering, and Production to keep the facility compliant.

You will lead new equipment IQ/OQ protocols, perform system verifications against P&IDs and vendor manuals, and drive periodic

Qualifications

• 3–5 years of validation or equipment qualification experience.
• Experience in a cGMP-regulated pharmaceutical manufacturing environment is preferred.
• Strong cross-functional collaboration skills across Facilities, Quality, and Operations.

Responsibilities

• Draft, review, and execute IQ/OQ protocols for small molecule processing equipment.
• Perform system field verification against P&IDs, vendor manuals, and site specs.
• Evaluate equipment functionality to ensure adherence to requirements.
• Perform periodic requalification evaluations and document CAPAs to prevent recurrence.
• Execute mapping studies for controlled environmental areas, including storage zones.

Skills

Qualification engineering

Project management

Excellent communication

Education

Bachelor's degree in Chemical Engineering or related Life Sciences

Job description

Olon USA in Concord, OH, is seeking an Equipment Qualification Engineer with 3–5 years of validation or qualification experience to manage GMP production equipment qualification lifecycle. The role focuses on IQ/OQ executions for small molecule processing equipment and collaboration with Maintenance, QA, Engineering, and Production to keep the facility compliant.

You will lead new equipment IQ/OQ protocols, perform system verifications against P&IDs and vendor manuals, and drive periodic