Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.
Our team is growing, and we are currently searching for a Facilities Engineer who is ready to play an instrumental role in constructing and operating our state-of-the-art GMP manufacturing facility. In this capacity, the engineer will lead initiatives in utilities management, equipment commissioning, cleanroom operations, quality system activities, and facility improvement projects, ensuring seamless and efficient operational workflows.
The ideal candidate will be adaptable, proactive, and have the ability to articulate complex information clearly and concisely to a broad audience. They must thrive in a fast-paced, matrixed environment and have experience in the pharmaceutical, biopharmaceutical, or medical device sectors. A deep understanding of cGMP, facility design, compliance, and best practices in the industry is essential.
- Troubleshoot utility equipment such as HVAC, compressed air, laboratory gases, vacuum, purified water, freezers, biosafety cabinets, fume hoods, and wastewater treatment system. Work cross functionally with internal departments and vendors to resolve issues
- Lead the installation, startup, and troubleshooting of utilities at our new manufacturing facility. Lead or coordinate training for equipment operation and maintenance
- Lead commissioning and qualification processes for our equipment, cleanrooms, and computer system. Activities may include defining user requirements, conducting system criticality and risk assessments, creating and managing engineering drawings, resolving non-conformances, and creating comprehensive engineering turnover packages
- Technical lead for the establishment of standards for asset management, maintenance, calibration, commissioning, engineering drawings, and other areas within the Facilities department
- Define maintenance and calibration requirements in order to accurately enroll assets into our computerized maintenance and calibration management system
- Support our Environment, Health, and Safety (EHS) programs by conducting risk assessments, job hazard analyses, and implementing projects to improve safety and environmental sustainability
- Own GMP quality systems activities including Change Control Requests (CCR), deviations, Corrective and Preventive Actions (CAPA), document control, validation, quality risk management (QRM), training, and audits
- Define a risk-based alarm classification in our Environmental Management System (EMS) and Building Management System (BMS)
- Lead facility improvement projects, managing scheduling, budgeting, and cross-functional coordination, with a strong emphasis on quality assurance
- Bachelor’s degree in chemical engineering, mechanical engineering, or related engineering field.
- A minimum of 5 years' experience as facilities engineer or similar role.
- Strong GMP experience and behaviors.
- Excellent project management skills, with the ability to handle multiple projects simultaneously.
- Strong verbal and written communication skills.
- Exceptional problem-solving skills, adaptability, and an ability to work under pressure and meet deadlines.
At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit cover letter and resume.
Lyra Therapeutics is an equal opportunity employer.