Manufacturing Sciences & Technology (MSAT) Process Engineer, 2nd/3rd Shifts jobs in United States
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Orca Bio · 2 days ago

Manufacturing Sciences & Technology (MSAT) Process Engineer, 2nd/3rd Shifts

Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. The MSAT Process Engineer is responsible for improving the efficiency and safety of the drug product manufacturing process, including lifecycle management of commercial products and troubleshooting manufacturing events.

Health CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

GMP manufacturing experienceBiotechnology manufacturingProcess monitoringRoot cause analysisChange control managementTechnical protocol writingCommunicationProblem solving

Required

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
Strong communication and problem solving skills, with a desire to improve upon established processes
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
Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed
Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs
Must be comfortable regularly participating in video-based meetings
May be required to work scheduled overtime, weekends, or holidays based on business needs

Preferred

Experience in biotechnology and cell therapy manufacturing

Benefits

Pre-IPO equity
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

Company

Orca Bio

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Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.

H1B Sponsorship

Orca Bio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (1)

Funding

Current Stage
Late Stage
Total Funding
$542M
Key Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M

Leadership Team

J
Jeroen Bekaert
Co-Founder and Chief Operating Officer
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Company data provided by crunchbase