R&D Engineer II, Sustaining; Chemical

Overview

Our Mission:
At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed. We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations.

• Provide hands‑on manufacturing floor support to independently troubleshoot and resolve equipment, tooling, and process issues impacting production, yield, and quality.
• Diagnose and correct mechanical, electrical, pneumatic, and basic controls/software issues; perform structured root cause analysis and implement effective corrective and preventive actions.
• Serve as equipment owner for assigned manufacturing systems, including setup, calibration, maintenance coordination, performance monitoring, and reliability improvement.
• Lead and execute equipment and process validation activities (IQ/OQ/PQ) with minimal supervision, ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
• Collaborate with Quality to investigate nonconformances, deviations, and CAPAs related to manufacturing equipment and processes.
• Support new product introductions and engineering changes by partnering with R&D and Operations to ensure manufacturability, scalability, and equipment readiness.
• Analyze production data, downtime, and yield trends to identify issues and drive continuous improvement initiatives using lean and data‑driven methodologies.
• Support supplier interactions related to equipment, tooling, and automation, including specifications, FAT/SAT participation, and issue resolution.
• Ensure adherence to safety requirements, GMPs, and regulatory standards while balancing the demands of a fast‑paced startup manufacturing environment.
• Contribute to scaling manufacturing operations through equipment upgrades, line expansions, and process standardization efforts.

• Train and mentor Manufacturing Engineers I and manufacturing technicians on equipment operation, troubleshooting techniques, and best practices.

• Bachelor’s degree (B.S.) in Engineering or equivalent in related field.
• Two to five years related experience or equivalent, FDA‑regulated (210/211/820).
• Two to four years of related experience leading a team of technicians and/or engineers.
• Excellent written and oral communication skills across all levels – technicians to executives.
• Demonstrates strong technical writing and investigative writing capability.
• Familiarity with process validation, change control, and equipment qualification.
• Six Sigma Green or Black belt certification preferred.
• Experience with CMMS, ERP/MRP, or MES systems preferred.
• Commitment to excellence and high standards.
• Basic competence in subordinates’ duties and tasks.
• Strong organizational, problem‑solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Acute attention to detail.
• Demonstrated ability to plan and organize projects.
• Proven ability to handle multiple projects and meet deadlines.
• Good judgement with the ability to make timely and sound decisions.
• Creative, flexible, and innovative team player.
• Working knowledge of data collection, data analysis, evaluation, and scientific method.
• Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We kindly request that recruiting agencies or third‑party recruiters do not contact us regarding this position.