Equipment Engineer
Orca Bio
Sacramento, CA, USA
Posted on Tuesday, August 13, 2024
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 late-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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Responsibilities:
The Equipment Engineer is responsible for production and laboratory assets across multiple production sites producing clinical and commercial drug products. This role involves providing technical expertise and maintenance coordination/execution (preventative and corrective maintenance, calibrations & certifications)for production and laboratory equipment to ensure compliant and reliable asset operations to support production requirements and meet customer needs.
Duties
- 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
- Coordination of onsite and maintenance, calibration and certification activities completed by service providers
- Execution of preventative and corrective maintenance tasks
- Review and approval of service provider documentation
- Completion and closeout of tasks in the CMMS
- Ensure that production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards
- Develop and deliver training in support of asset operations, maintenance, and reliability
- Collaboration with peers in the continuous improvement of production and laboratory equipment standards, practices, specifications, procedures, qualifications and business processes
- Collaboration with site MSAT and Engineering on new equipment installations, technology development and existing equipment modifications
- Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems
- Execution of small projects and continuous improvements
- Other duties as assigned
Education & Experience Requirements
- Bachelor’s degree in Engineering or Life Sciences, and prior work experience in a GMP manufacturing environment required
- 4 years of experience in GMP manufacturing facility, including production equipment operation, troubleshooting and maintenance execution
- Experience in analyzing, managing, and reporting reliability metrics, and use of a CMMS preferred
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 production and quality control 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
- 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
- Strong problem-solving skills with desire to improve upon established processes
- 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
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.
To learn more: https://orcabio.com/join-our-team/
**all official communication will be from @orcabio.com; please beware of scams**
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.
