EQUIPMENT QUALIFICATION ENGINEER

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

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EQUIPMENT QUALIFICATION ENGINEER

Full Time Other Professional-B Concord, OH, US

8 days ago Requisition ID: 1134

Equipment Qualification Engineer

Job Overview

We are seeking a detail-oriented and proactive Equipment Qualification Engineer with 3-5 years of experience to join our site. This role focuses on managing the qualification lifecycle of GMP production and manufacturing equipment in a small molecule API production facility. The ideal candidate will spearhead new production equipment IQ/OQ executions, lead periodic requalification assessments, and execute mappings for environmentally controlled areas. You will work cross-functionally with Maintenance, Quality Assurance, Engineering, and Production to maintain our facility in a continuous state of compliance.

Key Responsibilities

New Production Equipment IQ/OQ

• Protocol Development & Execution: Draft, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for small molecule processing equipment.
• System Field Verification: Physically verify manufacturing equipment installations against P&IDs, vendor manuals, and site engineering specifications.
• Operational Testing: Evaluate and test production equipment functionality to assure adherence to functional requirements.

Requalification Activities

• Periodic Review Cycles: Perform periodic requalification evaluations of existing production systems to ensure they remain in a validated state.
• Deviation Resolution: Identify, investigate, and document technical deviations or out-of-specification results during qualification executions on the shop floor, authoring robust CAPAs to prevent recurrence.

Environmental Controlled Area Mapping

• Execution & Analysis: Execute mapping studies for controlled environmental areas, including raw material/finished goods storage areas while also providing support for stability and analytical chambers.

Required Skills & Qualifications

• Education: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related Life Sciences discipline.
• Experience: 3-5 years of validation or equipment qualification experience. Preferably in a cGMP-regulated pharmaceutical manufacturing environment, with a focus on manufacturing floor equipment.
• Collaborative Nature: Strong project management mindset coupled with the communication skills required to manage cross-functional initiatives across Facilities, Quality, and Operations teams.