Manufacturing Process Engineer
Core
Identify and mitigate manufacturing issues for aseptic filling and capping/lyo operations using engineering and process improvement methods.
Role type
Manufacturing Process Engineer
Builds
Production processes, equipment modifications, and validation protocols for biopharma manufacturing
Domain
Biopharma / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lean Six Sigma, GMP compliance, root cause analysis, equipment commissioning, SOP development, data analysis, project management, change control
Preferred skills
Parenteral processing equipment experience, FAT/SAT leadership, IQ/OQ execution, advanced aseptic filling technology knowledge
Technologies
Aseptic Filling Isolator, GMP documentation systems
Responsibilities
Troubleshoot process manufacturing equipment and support corrective actions; Write and execute engineering protocols and SOPs; Lead commissioning, qualification, and validation of process equipment; Maximize manufacturing success rates by minimizing human error and mechanical failures; Collaborate on new manufacturing equipment performance requirements; Lead manufacturing investigations and CAPA initiatives
Seniority
Mid-level, hands-on IC
