Director, Facilities Engineering
Sanaria Inc., a Rockville, MD based biotechnology company, offers a unique and challenging opportunity to join a world class team to work on the development and commercialization of an attenuated sporozoite malaria vaccine. We currently have an opening for a Director, Facilities Engineering, reporting to the EVP, Process Development and Manufacturing.
This position will primarily be responsible for providing technical and engineering support to Sanaria’s multi-product manufacturing facility located in Rockville MD. Our facility is a state-of-the-art facility built to meet the US and EU requirements for aseptic manufacturing of Sanaria’s novel malaria vaccine. The Director of Facilities Engineering will work closely with the manufacturing, quality and the validation teams to develop and maintain the facility in a state of control for cGMP manufacturing. This position will also work closely with the validation engineers to complete ongoing facility qualification/validation and commissioning activities. This position is a supervisory position and will be responsible for managing and prioritizing the team’s responsibilities to align with the manufacturing timelines.
Facilities Engineering Primary Responsibilities:
- Manage scheduling of and oversee all facility and equipment calibration and preventative maintenance programs. The equipment includes but is not limited to AHUs, Autoclave, dishwasher, Purified water system, CTUs, BSCs, Laminar flow benches, REES monitoring system, BMS monitoring system etc.
- Perform routine facility inspection to ensure facility and equipment are in a state of control for GMP activities. Give recommendations to senior management on improving and or upgrading current systems.
- Implement SOP(s) and documentation procedures for the facility and equipment scheduled and unscheduled maintenance.
- Oversee building modifications, shutdown planning, equipment upgrade, facility repairs and upgrades.
- The successful candidate will also be responsible for maintaining equipment history files, writing PM and Calibration documents, scheduling outside service vendors and ordering spare parts.
- Complete deviations, change control and other facility/equipment related investigations in compliance with Sanaria quality SOP(s).
Qualified candidates will have a BS degree, preferably in an engineering discipline, and a minimum 5 years’ of GMP facility management with at least 2 years in a senior level role. Experience in clean room facility management is required. Good communication, interpersonal, organizational and customer services skills are essential. Proven troubleshooting skills – down to the component level and proficiency with all MS Office products are necessary. CAD experience, knowledge of HVAC and refrigeration systems and GAMP 5 knowledge are preferred.
To apply, send cover letter and resume to careers @sanaria.com, subject line: “Director, Facilities Engineering.” Candidates must have long-term eligibility to work in the US without sponsorship. Sanaria is an equal opportunity employer. For more information, see our website, www.sanaria.com.