ProKidney Corp
MSAT Engineer Winston-Salem, North Carolina, United States
ProKidney Corp, Jackson, Mississippi, United States
Winston-Salem, North Carolina, United States
Position Summary:
The role of MSAT Engineer will support technical transfer and ongoing process performance within a GMP-regulated manufacturing environment. This role will serve as a key technical owner of critical process deliverables—including the Bill of Materials (BoM), process flow diagrams, process descriptions, and equipment lists—and will play an essential part in ensuring robust, compliant, and efficient operations. The Process Engineer will partner closely with Manufacturing, QA, Validation, and Regulatory functions to enable successful production, investigations, and continuous improvement.
Lead and support
material qualification activities , including technical assessments, documentation, and implementation to ensure materials meet process and quality standards. Contribute to
technology transfer activities , including authoring and reviewing technical reports, protocols, and SOPs. Own and maintain
core process deliverables
such as the BoM, process descriptions, process flow diagrams, and equipment lists throughout the product lifecycle. Generate, analyze, and maintain the
Process Performance Report , ensuring processes remain in control and identifying opportunities for improvement. Execute
technical studies and investigations
to resolve deviations, support CAPA development, or enable process improvements. Partner cross-functionally with QA, Manufacturing, Validation, and Regulatory to ensure effective execution of investigations, audits, and regulatory commitments. Support and document
change control activities
related to processes, equipment, and materials. Qualifications: Bachelor’s or master’s degree in chemical engineering, Biotechnology, Life Sciences, or related discipline 5+ years of experience in pharmaceutical, biotechnology, or cell therapy manufacturing within a GMP environment. Experience with
digital manufacturing systems
(e.g., MES, EBR) preferred. Proven experience with
technical documentation
and ownership of process deliverables. Familiarity with
technology transfer
and
material qualification . Strong understanding of
pharmaceutical unit operations
and GMP manufacturing processes. Working knowledge of
GMP and regulatory requirements
(FDA, EMA, ICH). Excellent
technical writing, documentation, and communication skills . 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.
#J-18808-Ljbffr
material qualification activities , including technical assessments, documentation, and implementation to ensure materials meet process and quality standards. Contribute to
technology transfer activities , including authoring and reviewing technical reports, protocols, and SOPs. Own and maintain
core process deliverables
such as the BoM, process descriptions, process flow diagrams, and equipment lists throughout the product lifecycle. Generate, analyze, and maintain the
Process Performance Report , ensuring processes remain in control and identifying opportunities for improvement. Execute
technical studies and investigations
to resolve deviations, support CAPA development, or enable process improvements. Partner cross-functionally with QA, Manufacturing, Validation, and Regulatory to ensure effective execution of investigations, audits, and regulatory commitments. Support and document
change control activities
related to processes, equipment, and materials. Qualifications: Bachelor’s or master’s degree in chemical engineering, Biotechnology, Life Sciences, or related discipline 5+ years of experience in pharmaceutical, biotechnology, or cell therapy manufacturing within a GMP environment. Experience with
digital manufacturing systems
(e.g., MES, EBR) preferred. Proven experience with
technical documentation
and ownership of process deliverables. Familiarity with
technology transfer
and
material qualification . Strong understanding of
pharmaceutical unit operations
and GMP manufacturing processes. Working knowledge of
GMP and regulatory requirements
(FDA, EMA, ICH). Excellent
technical writing, documentation, and communication skills . 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.
#J-18808-Ljbffr