Technician, Facilities/Maintenance - Night Shift
PharmaBiotechRegulatory AffairsQuality Assurancegmpemacro
Job description
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Technician, Facilities/Maintenance - Night Shift is responsible for supporting the maintenance and repair of facilities and associated infrastructure across multiple production sites producing clinical and commercial drug products. This role involves utilization of a Computerized Maintenance Management System (CMMS) to execute and document preventative and corrective maintenance activities to ensure compliant and reliable operations to support production requirements to meet customer needs. Night Shift Hours Worked:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday Physical Demands & Work Conditions
Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
Must be comfortable regularly participating in video-based meetings. Job Duties and Key Responsibilities
Perform or coordinate preventive and corrective maintenance on the facility and associated infrastructure
Coordinate onsite preventative and corrective maintenance to be completed by service providers
Escort of service providers in restricted access areas during execution of facility and asset maintenance activities
Review and approval of service provider documentation, and completion of tasks in the CMMS
Maintain documentation in accordance with company standards
Ensure that facilities and associated infrastructure are maintained to applicable regulatory and GMP requirements
Participate in the continuous improvement of facility standards, specifications, procedures, and business processes
Other duties as assigned
Respond to emergency maintenance requests during off-hours as needed Education & Experience Requirements
High school diploma or GED required, associate’s degree or certification in facility maintenance preferred
2 years of experience in GMP manufacturing facility, preferably cell therapy, biotechnology or pharmaceutical
Experience in use of a CMMS system for managing execution of maintenance activities
Experience in execution of preventative and corrective maintenance of a GMP manufacturing facility and associated infrastructure
Experience coordinating onsite maintenance activities completed by service providers Personal Qualities & Physical Demands
Ability to multitask and manage multiple responsibilities simultaneously; able to prioritize Demonstrates strong work ethic and problem-solving skills
Willing to support sites after-hours on an as needed or on-call basis
Strong people skills and ability to communicate effectively
Ability to gown and work in cleanroom areas
Ability to work in a collaborative manner, independently and as part of a team
Ability to work in a fast-paced start-up environment while following documented procedures and instructions.
Ascend/descend stairs within the workspace; job requires sitting, standing, walking
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