Engineer, Manufacturing Sciences & Technology (MSAT) (3rd Shift)

Orca Bio; Sacramento (CA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Life and accidental death and disabil

Parental leave benefits

Subsidized daily lunches and snacks

Job summary

Orca Bio is seeking an Engineer I, MSAT, to improve efficiency and safety of the drug product manufacturing process at our Sacramento facility. The role involves life cycle management of commercial products, process monitoring, troubleshooting, and supporting investigations under guidance from senior engineers.

The position is 3rd shift (Mon-Fri, 11:00pm–7:00am) with benefits and growth opportunities in a fast-paced biotech environment in Sacramento, CA.

Qualifications

• Bachelor's degree in engineering or a related field.
• 0-2 years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing.
• Prior experience in regulated, GMP manufacturing operations.

Responsibilities

• 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.
• 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.
• Supports the authoring, execution and ownership of change controls, CAPAs, technical protocols, reports and activities to support improvements.

Skills

Strong communication

Problem solving

Education

B.S. in Engineering or related field

Job 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 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. The Engineer I works on well‑defined problems with clear scope and known troubleshooting paths, typically under guidance from more senior engineers or a manager.

Physical Demands

• 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.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. 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.

Work Conditions

• 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.

Essential Duties & Key Responsibilities

• 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
• 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
• Supports the authoring, execution and ownership of change controls, CAPAs, technical protocols, reports and activities to support improvements
• Ensures proper execution of validation protocols and testing in line with required life cycle management activities
• Troubleshoots issues within a defined scope, seeking guidance from senior team members as needed
• Supports validation activities, technical studies, and process improvement projects under the direction of senior engineers
• Learns from experienced engineers and contributes to collaborative problem‑solving efforts

Minimum Qualifications

• B.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
• Strong communication and problem‑solving skills, with a desire to improve upon established processes

3rd Shift

• Monday - Friday, 11:00pm - 7:00am

Preferred Qualifications

$85,000 - $105,000 a year

Benefits

• Pre‑IPO equity and annual bonus
• Competitive medical, dental, and vision benefits
• PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• 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 rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.