Engineer (Process Engineering)
Core
Process Engineer providing operation and New Product Introduction (NPI) support for biologics products and process equipment in a biotechnology manufacturing facility.
Role type
Process Engineer (System Owner)
Builds
Biologics manufacturing operations and new product introductions
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification, deviation investigations, change control management, asset lifecycle planning, commissioning and qualification (IQ/OQ/PQ), project management, root cause analysis, business case development, user requirement specifications, quality risk assessments, design specifications, system walk-downs, punch item closure, maintenance strategy development, spare parts planning, big data analysis for predictive monitoring, benchmarking equipment performance, technical solution development for complex problems.
Preferred skills
None stated
Technologies
Maximo, big data analysis tools
Responsibilities
Present equipment qualification and investigation records during regulatory inspections; lead equipment breakdown investigations to identify root causes; implement corrective and preventive actions; manage asset lifecycle planning; support New Product Introduction readiness; work with project managers on new equipment design and commissioning; develop technical solutions for complex engineering problems.
Seniority
Individual Contributor (IC), entry to mid-level
