MSAT Process EngineerOrca 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 clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.Essential Duties & Key Responsibilities:Performs ongoing monitoring of existing products and processesGenerates metrics and reports for process monitoring and continuous process verificationSupports process improvements and changes including electronic batch record creation and modificationsInvestigaes process events and implements corrective and preventive actionsProvides troubleshooting support for manufacturing events, equipment performance and material issuesPerforms root cause analysis to isolate cause of events and determine appropriate corrective actionsAuthors, executes and owns change controls, technical protocols, reports and activities to support improvementsWrites and ensures proper execution of validation protocols and testing in line with required life cycle management activitiesMinimum Qualifications:B.S.
in Engineering or similar fields3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industriesPrior experience in regulated, GMP manufacturing operationsExperience in biotechnology and cell therapy manufacturing preferredStrong communication and problem solving skills, with a desire to improve upon established processesFlexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.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.$80,000 - $100,000 a yearThe 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.