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Operations Process Engineer II
On-site · Cincinnati, Ohio, United States
Job Summary
Operations Process Engineer II develops robust and compliant procedures for Operations, executes corrective actions for process failures, and drives continuous improvements to address gaps in process. SME in Oral Solid Dose manufacturing, supporting quality investigations and cross-functional discussions to resolve root causes and drive CAPA. Responsibilities include leading quality incident response, facilitating root-cause analysis and corrective actions, revising and maintaining manufacturing procedures for GMP compliance, and tracking quality metrics to drive RFT initiatives. The role also involves authoring digital forms for setup/run/clean batch activities in the Digital Logbook system, and collaborating with Quality, Tech Services, Engineering, and other teams to ensure investigations and deviations meet cGMPs, SOPs, and customer requirements. Requires a Bachelor’s degree in engineering or science, 2+ years of related experience, and ability to work with diverse teams; relocation is not provided, and sponsorship is not required.
Required Qualifications
- Bachelor’s Degree in Engineering or Science related field is required
- Minimum 2 years experience in continuous improvement, Operations SME, and/or Technical SME Quality, process and manufacturing investigation and technical writing experience is preferred
- Background in cGMP’s requirements is preferred
- Lean Six Sigma problem solving skills is preferred
- Proficiency with Microsoft Office Word, Excel and PowerPoint
- Ability to learn and navigate through investigation, quality and ERP systems
- Models effective and constructive communication and interactions with technical departments both orally and in writing
Additional Requirements
- Must be legally authorized to work in the United States now or in the future, without sponsorship.
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