EQUIPMENT QUALIFICATION ENGINEER

Olon USA LLC • Concord Township, OH

5h

About The Position

We are seeking a detail-oriented and proactive Equipment Qualification Engineer to manage the qualification lifecycle of GMP production and manufacturing equipment in a small molecule API production facility. The role focuses on new production equipment IQ/OQ executions, periodic requalification assessments, and mapping studies for environmentally controlled areas. The engineer works cross-functionally with Maintenance, Quality Assurance, Engineering, and Production to maintain the facility in a continuous state of compliance.

Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related Life Sciences discipline.
• 3–5 years of validation or equipment qualification experience.
• Strong project management mindset and communication skills to manage cross-functional initiatives across Facilities, Quality, and Operations.

Nice To Haves

• Experience in a cGMP-regulated pharmaceutical manufacturing environment, preferably focused on manufacturing floor equipment.

Responsibilities

• Draft, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for small molecule processing equipment.
• Physically verify manufacturing equipment installations against P&IDs, vendor manuals, and site engineering specifications.
• Evaluate and test production equipment functionality to assure adherence to functional requirements.
• Perform periodic requalification evaluations of existing production systems to ensure they remain in a validated state.
• Identify, investigate, and document technical deviations or out-of-specification results during qualification executions on the shop floor, and author CAPAs to prevent recurrence.
• Execute mapping studies for controlled environmental areas, including raw material and finished goods storage areas, and support stability and analytical chambers.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level