GMP Equipment Qualification Engineer

Olon USA LLC; Concord Township (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Olon USA LLC is seeking an Equipment Qualification Engineer in Concord, Ohio. The role focuses on qualification lifecycle management for GMP production equipment in a small molecule API facility, driving IQ/OQ executions and requalification activities.

You will collaborate with Maintenance, Quality Assurance, Engineering, and Production to keep the facility in a continuous state of compliance, including environmental area mapping and corrective actions as needed.

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering or a related Life Sciences discipline.
• 3–5 years of validation or equipment qualification experience in a cGMP pharmaceutical setting.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Develop and execute IQ/OQ protocols for small molecule production equipment.
• Physically verify equipment installations against P&IDs and site specs.
• Lead periodic requalification evaluations to maintain a validated state.
• Identify, investigate and document deviations; draft robust CAPAs.
• Map environmental controlled areas and support stability/analytical chambers.

Skills

Project management

Cross-functional collab

Effective communication

Education

Chemical/Mechanical Engineering degree

Life Sciences related degree

Related engineering field

Job description

Olon USA LLC is seeking an Equipment Qualification Engineer in Concord, Ohio. The role focuses on qualification lifecycle management for GMP production equipment in a small molecule API facility, driving IQ/OQ executions and requalification activities.

You will collaborate with Maintenance, Quality Assurance, Engineering, and Production to keep the facility in a continuous state of compliance, including environmental area mapping and corrective actions as needed.