ProKidney Corp
MSAT Sr. Engineer Winston-Salem, North Carolina, United States
ProKidney Corp, Jackson, Mississippi, United States
Overview
Winston-Salem, North Carolina, United States Position Summary:
The role of MSAT Senior Engineer will provide technical leadership for cell therapy manufacturing operations, ensuring processes are robust, scalable, and compliant with GMP standards. The Senior MSAT Engineer will play a critical role in technology transfer, process improvement, facility start-up, and regulatory readiness, supporting both clinical and commercial production. Responsibilities
Project & Facility Support Lead or support projects to improve process robustness, scalability, and GMP compliance. Contributes to the construction, qualification, and start-up of new commercial manufacturing facilities. Authorize, review, and approve technical documentation including project plans, test protocols, reports, and SOPs. Technical Process Support Serve as the MSAT point-of-contact for development, manufacturing, supply chain, QC, QA, and vendor projects. Provide hands-on technical support for cell processing operations, including troubleshooting and optimization. Lead investigations for process deviations, perform root cause analyses, and implement corrective/preventive actions (CAPAs). Data & Compliance Analyze process and project data, presenting clear findings and recommendations to stakeholders. Ensure compliance with cGMP, safety standards, and company SOPs. Support regulatory submissions by preparing technical documentation and data summaries. Act as a subject matter expert (SME) during inspections and audits. Identify risks in manufacturing processes and implement mitigation strategies. Assess and qualify raw materials, ensuring suitability, reliability, and supply chain continuity. Qualifications
Bachelor’s or master’s degree in chemical engineering, biochemical engineering, biotechnology, or related discipline 8+ years with a Bachelor’s or 6+ years with a Master’s in MSAT, cell therapy, or biopharmaceutical manufacturing. Proven leadership in
GMP project implementation, technology transfer, and process troubleshooting . Experience with process validation and lifecycle management preferred Strong understanding of cell therapy or biopharmaceutical processes, including aseptic processing, cell expansion, and purification. Familiarity with GMP, GLP, and regulatory requirements for cell-based therapies. Experience supporting regulatory submissions and audits. Experience handling human-derived materials in cleanroom environments. Familiarity with MES or ERP systems. Knowledge of ICH guidelines (Q8, Q9, Q10) and Quality by Design (QbD) principles. Excellent problem-solving, analytical, and critical-thinking abilities. Strong communication and technical writing skills (SOPs, batch records, reports). Ability to work effectively in cross-functional, fast-paced environments. Flexibility to occasionally support weekend manufacturing operations. Equal Employment Opportunity
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
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Winston-Salem, North Carolina, United States Position Summary:
The role of MSAT Senior Engineer will provide technical leadership for cell therapy manufacturing operations, ensuring processes are robust, scalable, and compliant with GMP standards. The Senior MSAT Engineer will play a critical role in technology transfer, process improvement, facility start-up, and regulatory readiness, supporting both clinical and commercial production. Responsibilities
Project & Facility Support Lead or support projects to improve process robustness, scalability, and GMP compliance. Contributes to the construction, qualification, and start-up of new commercial manufacturing facilities. Authorize, review, and approve technical documentation including project plans, test protocols, reports, and SOPs. Technical Process Support Serve as the MSAT point-of-contact for development, manufacturing, supply chain, QC, QA, and vendor projects. Provide hands-on technical support for cell processing operations, including troubleshooting and optimization. Lead investigations for process deviations, perform root cause analyses, and implement corrective/preventive actions (CAPAs). Data & Compliance Analyze process and project data, presenting clear findings and recommendations to stakeholders. Ensure compliance with cGMP, safety standards, and company SOPs. Support regulatory submissions by preparing technical documentation and data summaries. Act as a subject matter expert (SME) during inspections and audits. Identify risks in manufacturing processes and implement mitigation strategies. Assess and qualify raw materials, ensuring suitability, reliability, and supply chain continuity. Qualifications
Bachelor’s or master’s degree in chemical engineering, biochemical engineering, biotechnology, or related discipline 8+ years with a Bachelor’s or 6+ years with a Master’s in MSAT, cell therapy, or biopharmaceutical manufacturing. Proven leadership in
GMP project implementation, technology transfer, and process troubleshooting . Experience with process validation and lifecycle management preferred Strong understanding of cell therapy or biopharmaceutical processes, including aseptic processing, cell expansion, and purification. Familiarity with GMP, GLP, and regulatory requirements for cell-based therapies. Experience supporting regulatory submissions and audits. Experience handling human-derived materials in cleanroom environments. Familiarity with MES or ERP systems. Knowledge of ICH guidelines (Q8, Q9, Q10) and Quality by Design (QbD) principles. Excellent problem-solving, analytical, and critical-thinking abilities. Strong communication and technical writing skills (SOPs, batch records, reports). Ability to work effectively in cross-functional, fast-paced environments. Flexibility to occasionally support weekend manufacturing operations. Equal Employment Opportunity
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
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