Laboratory Maintenance Engineer
About the Organization
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.
Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. Our lead product candidates are RGX-314 for the treatment of wet age-related macular degeneration (wet AMD), RGX-501 for the treatment of homozygous familial hypercholesterolemia (HoFH), RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I) and RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II).
The Laboratory Maintenance Engineer will be responsible for operating and maintaining GMP and non-GMP equipment and facilities, building out/opening new lab facilities, working with HVAC and other base building systems that support lab functions and will develop and manage appropriate systems for GMP & non-GMP equipment management. The incumbent will work closely with outside contractors to coordinate facilities support and logistics as well as manage maintenance and calibration programs, including scheduling PM’s for GMP and non-GMP equipment.
- Support the build out and opening of new lab facilities
- Ownership for new equipment registration/commissioning
- Ownership of decommissioning, documentation and disposal of equipment
- Management and oversight of calibration and preventive maintenance of lab equipment, including review of contractor executed activities
- Oversight of VEM system and related VWR contractor
- Ownership and oversight of the Vaisala system
- Writing/review of Facilities related documents
- Facilities review of GMP change controls for lab/equipment moves
- Oversight for central utilities
- Management of validation contractors & coordination of validation for new/modified equipment and facilities
- Project planning and management, coordination with lab owners for new facility start-up
- Develop and manage appropriate systems for GMP & non-GMP equipment management
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
- Incumbent must have 5-10 years’ experience in a similar role
- Prior experience building out/opening new facilities a huge plus
- Ability to work cross-functionality and collaborate with several different departments
- Ability to work in a fast-paced, changing environment
- Must be mechanically inclined
- Must possess strong organization skills
- Ability to problem solve under high pressure situations
- Prior experience with GMP equipment and facilities
- Prior experience with Siemens Apogee System a big plus
- Prior experience in operating and maintaining GMP and non-GMP equipment and facilities
- Prior experience working with HVAC and other base building systems that support lab functions and will have the ability to develop and manage appropriate systems for GMP & non-GMP equipment management.
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
- Ability to respond to after hour alarms and perform corrective measures
- Working in GMP and general-purpose labs
- Ability to lift 50 pounds
Will supervise outside vendors and contractors
Maryland - Corporate
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.