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 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
- B.S. in Engineering or similar fields
- 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
- Prior experience in regulated, GMP manufacturing operations
- Experience in biotechnology and cell therapy manufacturing preferred
- Strong communication and problem solving skills, with a desire to improve upon established processes
Personal Qualities & Physical Demands
- Highly detail oriented with special attention to quality, compliance and safety
- Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
- Demonstrates strong work ethic, curiosity to learn and contribute
- Strong interpersonal skills and ability to communicate effectively
- Ability to work in a collegial and collaborative manner, independently and as part of a team
- Ability to work in a fast-paced start-up environment while following SOPs
- Highly tolerant and respectful of all team members
- A sense of humor is always appreciated
- Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
- Occasional need to ascend/descend stairs within workspace; job requires 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/
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