At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.
The role of this position is to help implement and maintain a Preventive Maintenance and Calibration program at Neurogene. This position will help maintain an uninterrupted supply of clinical materials by ensuring facilities and equipment are kept in a calibrated and operational state.
Accountabilities and Responsibilities
- Assist in development and implementation of Preventive Maintenance and Calibration procedures for key processes and equipment.
- Perform routine and non-routine maintenance on bioprocessing equipment in the facility.
- Operate and monitor plant support equipment including pharmaceutical water systems, boilers, HVAC and compressed air.
- Assist with maintaining an up-to-date working spare parts inventory system.
- Assist in start-up and qualification (validation) of new equipment installations and modifications.
- Perform troubleshooting of process and utility equipment.
- May collaborate with other departmental teams to complete specialized equipment maintenance projects such as equipment upgrades or changeover between products, etc.
- Write and review SOPs and change control documents for maintenance work areas.
- Ensure proper documentation is completed to meet quality systems requirements.
- Participate in facility safety programs.
- May be asked to perform various “housekeeping” activities such as keeping work areas and equipment clean, etc.
- Work Schedule – Day shift
- Travel <10%
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Quality Responsibility
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
- All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).
- Works on problems of moderate scope. Exercises judgment within defined procedures and policies in selecting methods and techniques in obtaining solutions and in determining appropriate action.
- Leadership Responsibility
- Minimum, Associates degree in engineering, electronics or other relevant field
- Bachelor’s degree preferred
- Minimum 3 years general maintenance experience
- Experience in GMP environment a plus
- Licenses or Certifications
- Certificate from Technical School preferred
- Working knowledge of utility control and building management systems
- Able to perform procedures according to written guidelines
- Able to develop new procedures when required
- Demonstrate skills in problem-solving and provide solutions
- Interact effectively with staff members from multiple levels and departments
- Able to clearly communicate observations with management from other departments
- Ability to lift 50lbs, assisted.
- Working Conditions
- A majority of the work is done in a warehouse or manufacturing environment. Work may involve high energy hazards, such as steam, high-pressure gases, flammable materials, high-temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases. In some areas, gowning (e.g. lab coat, face mask, shoe covers, hair and beard nets etc.) may be required.