The posting
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 Specialist, Facilities is responsible for facilities, utilities and production and laboratory assets across multiple production sites producing clinical and commercial drug products. This role involves providing technical expertise for asset operation and troubleshooting, and utilization of a Computerized Maintenance Management System (CMMS) to manage asset data, asset labelling, asset status, and to coordinate and execute preventative and corrective maintenance, calibration and certification activities to ensure compliant and reliable operations to support production requirements to meet customer needs. They will also be responsible for managing and executing various projects in support of facility and utility system operations.
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 responsibilities include:
- Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
- Track and report on equipment downtime, failure trends and develop corrective actions to prevent recurrence
- Planning, scheduling and coordinating onsite and offsite preventative and corrective maintenance, calibration and certification activities to be completed by service providers
- Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS
- Ensure that facilities, utilities, production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards
- Collaboration with peers in the continuous improvement of equipment standards, practices, specifications, procedures, qualifications and business processes
- Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems
- Execution of facility preventative and corrective maintenance tasks, small projects and continuous improvements
- Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans
- Other duties as assigned
Education & Experience Requirements:
- Bachelor’s degree in Engineering, Life Sciences, Facility Management or equivalent technical experience
- 4 years of experience in GMP manufacturing facility, including equipment operation and troubleshooting, and facilities and asset maintenance execution in a GMP manufacturing facility
- Experience in analyzing, managing, and reporting reliability metrics, and managing assets and maintenance activities using a CMMS system
- Experience coordinating onsite and offsite maintenance, calibration and certification activities completed by service providers
- Experience in managing and executing facility and utility projects including repairs, improvements and new installations.
Personal Qualities & Physical Demands:
- Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
- Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
- Willing to support sites after-hours on an as needed or on-call basis
- Strong interpersonal skills and ability to communicate effectively
- Strong problem-solving and critical thinking skills to support making decisions in a timely manner, and desire to improve upon established processes
- Ability to gown and work in clean room 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.
- Ability to work for extended periods of time at a computer
- Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking
The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
