GMP Equipment Qualification Engineer - Validation Expert

Olon Ricerca Bioscience Llc; Concord (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

Olon Ricerca Bioscience Llc is seeking an Equipment Qualification Engineer in Concord, OH to manage IQ/OQ and requalification for GMP production equipment. The role collaborates with Maintenance, QA, Engineering, and Production to keep the facility in a validated state.

The ideal candidate has 3–5 years of experience in validation or equipment qualification in a cGMP pharmaceutical environment, a Bachelor’s in a related engineering field, and strong project management and cross-functional

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related Life Sciences.
• 3–5 years of validation or equipment qualification experience in a cGMP pharmaceutical environment.
• Experience in managing qualification activities on manufacturing floor equipment.
• Strong cross-functional communication and project management skills.

Responsibilities

• Draft, review, and execute IQ and OQ protocols for small molecule processing equipment.
• Verify equipment installations against P&IDs, vendor manuals, and site specs.
• Evaluate production equipment function to ensure adherence to requirements.
• Perform periodic requalification evaluations and document CAPAs to prevent recurrence.
• Map controlled environmental areas and support stability and analytical chambers.

Skills

Detail-oriented

Cross-functional collaboration

Project management

Analytical thinking

Effective communication

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related Life Sciences

Job description

Olon Ricerca Bioscience Llc is seeking an Equipment Qualification Engineer in Concord, OH to manage IQ/OQ and requalification for GMP production equipment. The role collaborates with Maintenance, QA, Engineering, and Production to keep the facility in a validated state.

The ideal candidate has 3–5 years of experience in validation or equipment qualification in a cGMP pharmaceutical environment, a Bachelor’s in a related engineering field, and strong project management and cross-functional