Orca Bio

Engineer, Packaging and Labeling

Sacramento, CA · Full-time

Sponsorship not specified$85k-$105kDetected 6 days ago

GMPFDA RegulatoryLeadershipRegulatory Affairs

About the role

More than one million people in the United States today are fighting blood cancer.
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.
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.

Design, develop, qualify, and maintain packaging configurations for cryopreserved drug products.
Develop packaging solutions that protect product quality throughout manufacturing, storage, shipping, and administration.
Support lifecycle management of packaging systems from development through commercial manufacturing. Patient-Centric Delivery Execution
Develop packaging qualification protocols including Operational Qualification (OQ) and Performance Qualification (PQ).
Support thermal mapping, shipping validation, lane qualification, and transportation studies.
Analyze shipping performance data and implement corrective actions when necessary.
Support equipment qualification, preventive maintenance strategies, and lifecycle management.
Partner with Engineering and Validation to commission and qualify new cryogenic equipment.
Investigate equipment-related deviations and implement engineering improvements.

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.
Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.
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.
Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
Other perks include 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 embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

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 aren't afraid to ask "why not" and challenge the status quo.
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.

Evaluate new packaging technologies and recommend improvements to increase robustness, efficiency, and cost effectiveness.

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.

We are driven by a passion for science and compassion for patients.
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.

This listing is sourced directly from Orca Bio's careers page and normalized into a canonical job model.