Locus Biosciences is seeking a Facilities and Engineering Manager. A successful candidate will be responsible clinical-stage manufacturing site awarded by ISPE’s 2021 Facility of the Year Award – Honorable Mention. This role will be primarily responsible for the GMP facility, utilities, maintenance, calibration, equipment onboarding, BMS system, process engineering, work order system, and facility and equipment validation.
We are looking for the right candidate willing to who can roll up their sleeves as well as managing a small team of engineers and vendors. This position is vital role for Locus and the successful candidate will be included in the Locus Lead program, a leadership program supports the development both new and experienced leaders.
Responsibilities will include:
Prepare, submit and manage facility and engineering budget and hire, develop and train engineers.
Manage all facility electrical, HVAC (cGMP and non cGMP), plumbing, pest management inquiries, and upgrades.
Support and manage capital builds for new and existing construction.
Provide overall facility services including application of policies and programs, creation of the work order system, coordination of calibration and maintenance services (external vendors), and engineering projects.
Ensure compliance with portfolio wide initiatives and required local, state and federal laws and regulations that pertain to the operation of facilities.
Develop and implement innovative programs, processes and procedures that reduce short and long term operating costs and increase productivity.
Oversee the development and management of the capital and expense budgets.
Oversee and maintain the Building Management System (BMS).
Oversee and execute contracts and vendors associated with building services.
Assist with trouble-shooting facility and utility systems on an as needed basis which includes but not limited to chillers, air handler units (AHUs), WFI loops, clean steam generators, boilers, air compressors, process waste, etc.
Provide investigation, engineering and change control support for all systems including investigation of deviations of facility and utility systems or process equipment and the determination of the root cause, along with the development of corrective actions to prevent reoccurrence.
Possess the skills required to successfully lead, develop, and execute project tasks and deliverables, be a collaborative team player, handle 2-3 small projects at a time, establish and manage priorities, and have a strong drive to deliver quality projects.
Develop and implement engineering and design concepts for HVAC, Plant Steam / Condensate, and process utilities.
Understanding and delivery of the development of design documents and deliverables through the conceptual, preliminary, detailed, and construction phases of a project (P&lDs, distribution plans, onboarding, specifications, and qualification etc.).
Candidate must possess:
Previous facility experience in a large molecule, gene therapy, vaccines, phage therapy or similar GMP environment
Technical understanding and knowledge of various high purity water and HVAC systems within a GMP/GxP environment, plant utilities design and trouble-shooting, and all associated piping, pumping, heat transfer and distribution that make up these systems.
Familiarity with Process Gases, (Compressed Air, C02, N2, and 02), and technical knowledge of building automation systems (BAS/BMS/DCS) will also be an advantage.
S. degree in Engineering (Mechanical, Chemical or Process Engineering preferred)
1 to 3 years of experience required involving core utilities in industrial facilities, specifically GMP facility/capacity
Demonstrated experience in project management, time management and organizational skills.
Experience in troubleshooting, design and specification of clean room HVAC, plant utility, high purity water, and steam systems required.
At least 1 year in a supervisory capacity.
Computer skills include CMMS / BMS / MS Office Suite. CAD a plus.
Technical knowledge including PLC/controls, hydraulics, pneumatics, electrical, VFD’s, SCADA/BMS/DCS, etc.
Experience researching and interpreting building/mechanical/plumbing/electrical codes required.
Excellent communication skills in all forms.
About Locus Biosciences
Locus Biosciences is a clinical-stage biotechnology company developing CRISPR-enhanced precision antibacterial products (crPhage™) to address critical unmet medical needs in bacterial infections and microbiome indications in oncology, immunology and neurology therapeutic areas. The Locus platform combines CRISPR-Cas3, which permanently degrades target DNA within a bacterial cell, with bacterial viruses called bacteriophage to specifically kill target pathogens while leaving non-target bacteria (i.e., the rest of the patient’s microbiome) unharmed. Locus completed its first human clinical trial in early 2021, with a crPhage product targeting Escherichia coli bacteria in the urinary tract. Locus also recently announced strategic collaborations with Johnson & Johnson, BARDA, and CARB-X to develop crPhage products targeting respiratory infections, E. coli urinary tract infections, and Klebsiella pneumoniae infections, respectively. For more information about Locus visit https://www.locus-bio.com/
Job Type: Full-time
Job Location: Research Triangle Park, North Carolina
For immediate consideration, please apply online at https://www.locus-bio.com/careers/ OR email your resume or CV to firstname.lastname@example.org.
Direct applicants only. No agencies please.