Process Engineering Manage

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.

Engineer I, MSAT, 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. Production Associate Roles: 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.

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.

Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Performs ongoing monitoring of existing commercial products and processes

Generates metrics and reports for process monitoring and continuous process verification

Supports process improvements and changes including electronic batch record creation and modifications

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

Ensures proper execution of validation protocols and testing in line with required life cycle management activities

Supports validation activities, technical studies, and process improvement projects under the direction of senior engineers

S. in Engineering or similar fields, or equivalent combination of education and directly relevant experience

0-2 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

3rd Shift:

Monday - Friday, 11:00pm - 7:00am

$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. For remote-based positions, this range may vary based on your local market.

pre-IPO equity

annual bonus

competitive medical benefits

dental benefits

life and accidental death and disability coverage

subsidized daily lunches and snacks at our on-site locations

We are driven by a passion for science and compassion for patients. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. 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.

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.

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