About the role
The Site Engineer is responsible for overseeing the maintenance, calibration, operational readiness of equipment, utilities, and facilities supporting cGMP manufacturing and laboratory areas. This role is integral to ensure the efficient, reliable, and compliant operation of our facility. The ideal candidate will bring a strong background in engineering, technical problem-solving, and cross-functional collaboration.
What you'll do
Facility & Equipment Maintenance & Operation:
- Manage and oversee the maintenance and calibration of manufacturing equipment, utilities (e.g., HVAC, purified water systems, compressed air), and laboratory instruments to ensure compliance with cGMP standards.
- Provide engineering oversight for laboratory and manufacturing equipment and spaces for new implementation or troubleshooting issues.
- Ensure facilities meet industry standards, regulations, and company policies, including Good Manufacturing Practices (GMP).
- Support the site’s preventive maintenance program to minimize downtime and extend the life of critical systems and equipment.
- Provide engineering expertise to troubleshoot and resolve equipment and system issues, minimizing downtime and maintaining operational efficiency. Collaborate with contractors and vendors for repairs, upgrades, and calibration services, ensuring timely and cost-effective execution of work.
- Develop and maintain technical documentation, including maintenance records, calibration logs, and validation reports, in alignment with cGMP and company standards.
- Identify and implement continuous improvement projects to enhance operations, reduce costs, and increase efficiency.
Quality and Regulatory Compliance:
- Coordinate and execute commissioning, qualification, and validation (CQV) activities for new and existing equipment and systems.
- Ensure compliance with local, state, and federal regulations, including OSHA, EPA, and GMP standards.
- Prepare for and participate in audits by regulatory bodies and internal inspections.
- Assist with the preparation and maintenance of facility and equipment documentation, including maintenance logs, system manuals, and regulatory compliance reports.
Project Management:
- Work with vendors, contractors, and internal teams to manage capital projects, installation of new systems, and equipment maintenance and calibration activities.
- Plan, design, and implement improvements or expansions, ensuring projects are completed on time, within budget, and in compliance with regulations.
- Coordinate upgrades to utilities, building systems, and equipment as necessary to support production needs.
Energy and Resource Management:
- Monitor and optimize energy usage across the facility to reduce costs and environmental impact.
- Evaluate and recommend improvements in energy efficiency and sustainability practices.
- Maintain effective waste management systems in line with environmental regulations.
Cross-functional Collaboration:
- Work closely with other teams to ensure facility systems meet operational and safety requirements.
- Provide technical support for production processes that rely on facility systems (e.g., clean rooms, temperature-controlled storage, etc.).
- Train staff on facility systems and best practices for operating and maintaining equipment.
Documentation & Reporting:
- Maintain accurate records of maintenance activities, system performance, and regulatory compliance.
- Support EHS initiatives with respect to equipment, utilities, and facilities.
- Prepare reports on facility performance, energy usage, and system efficiencies for management review.
- Ensure that all necessary documentation is prepared and up-to-date for inspections or audits.
Qualifications
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
- 5+ years of experience in equipment maintenance, metrology, or facility engineering in a regulated or biopharmaceutical environment.
- Experience with HVAC, electrical systems, clean room environments, and utility systems used in biopharmaceutical manufacturing.
- Process engineering knowledge a plus
- Familiarity with GMP, FDA, OSHA, and other relevant regulatory standards.
- Strong technical problem-solving skills and the ability to work effectively in a fast paced, cross-functional environment.
The level of this position will be based on the final candidate’s qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
About COUR
COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR’s platform of immune-modifying nanoparticles aims to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression.