Manufacturing Process Engineer
Core
Identify and mitigate manufacturing issues for aseptic filling and capping/lyo operations, ensuring process compliance and efficiency in a biopharma setting.
Role type
Manufacturing Process Engineer
Builds
Production lines for parenteral products using advanced filling isolator technology
Domain
Biopharma / Parenteral Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Lean Six Sigma, GMP compliance, equipment commissioning, SOP development, data analysis, project management
Preferred skills
Parenteral processing equipment knowledge, team management, technical communication, complex problem solving
Technologies
Aseptic Filling Isolator, FAT/SAT equipment, IQ/OQ systems
Responsibilities
Troubleshoot process manufacturing equipment and minimize human/mechanical errors; Write SOPs, test procedures, and GMP batch records; Lead commissioning, qualification, and validation of process equipment; Conduct data gathering and analysis to minimize waste and variability; Lead manufacturing investigations and CAPA initiatives; Collaborate on new equipment performance requirements and line layout optimization.
Seniority
Mid-level, hands-on IC
