Lead Pharmaceutical Process Engineer
Core
Lead the design, development, implementation, and optimization of pharmaceutical manufacturing processes for solid dosage forms, sterile manufacturing, or biopharmaceutical products.
Role type
Lead Pharmaceutical Process Engineer
Builds
Robust and efficient manufacturing processes for pharmaceutical products
Domain
Pharmaceutical manufacturing / Chemical Engineering
Required skills
Process design, Process scale-up, Process validation, GMP compliance, cGMP knowledge, FDA regulations, Project management, Technical leadership, Hazard analysis, Continuous manufacturing technologies
Preferred skills
Solid dosage forms expertise, Sterile manufacturing expertise, Biopharmaceutical processes expertise, Automation systems knowledge, Continuous manufacturing technologies
Technologies
Process control systems, Automation systems, Continuous manufacturing technologies
Responsibilities
Lead the design, development, and implementation of innovative pharmaceutical manufacturing processes; Oversee process scale-up activities from laboratory to pilot plant and commercial production; Develop and execute process validation protocols and reports; Optimize existing manufacturing processes to improve yield, efficiency, and reduce costs; Troubleshoot and resolve complex process-related issues in a manufacturing setting; Ensure all processes comply with cGMP, FDA, and other relevant regulatory standards; Provide technical leadership and mentorship to a team of process engineers and technicians; Conduct process hazard analyses and implement appropriate safety measures.
Seniority
Senior, hands-on IC with leadership responsibilities
