- Professional
- Ufficio in Winston-Salem
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.
Essential Duties & Responsibilities:
- 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.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
