What are the responsibilities and job description for the Manufacturing Sciences & Technology (MSAT) Process Engineer, 2nd Shift position at Orca Bio?
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.
The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective / preventive actions. This is a 2nd Shift / Swing position with a Monday through Friday schedule from 3-11 : 30pm.
Responsibilities
- Performs ongoing monitoring of existing commercial products and processes
- Generate metrics and reports for process monitoring and continuous process verification
- Support process improvements and changes including electronic batch record creation and modifications
- Investigates process events and implements corrective and preventive actions
- Provides troubleshooting support for manufacturing events, equipment performance and material issues
- Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
- Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
- Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities
Education & Experience Requirements
Personal Qualities & Physical Demands
The anticipated annual salary range 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, including shift differential pay . You will also be eligible to receive pre-IPO equity, in addition to medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free 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.
To learn more : https : / / orcabio.com / join-our-team /
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