Senior Process Engineer

Role: Senior Process Engineer in sterile manufacturing, responsible for developing and transferring aseptic production processes for biopharmaceutical products from concept to launch, including scale-up, validation, and continuous improvement. Responsibilities: design and execute regulatory-compliant protocols, monitor manufacturing data, troubleshoot equipment and process deviations, and lead process improvements. Collaborates closely with R&D and manufacturing teams to ensure smooth transition to commercial production, and evaluates new technologies to enhance capabilities. Provides SME-level expertise in sterile/aseptic filling, formulation, lyophilization, and contamination control; develops SOPs, manages change controls, and supports investigations and CAPA activities. Qualifications: BA/BS in engineering, manufacturing, or related field; 5+ years in GMP sterile/aseptic manufacturing, with strong knowledge of FDA regulations and cGMP standards. Preferred: MS/MA in related discipline. Skills: project management, problem-solving, cross-functional communication, proficiency with engineering tools. High-Value: sterile/aseptic biopharma manufacturing, process validation, regulatory compliance, troubleshooting, process optimization, cross-disciplinary collaboration, GMP environment. Work setup: unspecified; salary range $100,000–$120,000, with benefits.