Senior Project Engineer
Core
Manage implementation of projects for manufacturing terminal sterilized pharmaceuticals in Polypropylene bags using freeflex® bag technology.
Role type
Senior Project Engineer (Pharmaceutical Manufacturing)
Builds
Terminal sterilized pharmaceutical products in Polypropylene bags
Domain
Pharmaceutical manufacturing / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
project management, equipment installation, supplier coordination, process analysis, root cause analysis, risk assessment, validation activities, budgeting, training development, data interpretation, critical process parameter analysis
Preferred skills
experience with PVC free IV bag material technology, facility modifications, process improvement initiatives
Technologies
freeflex® bag technology, cGMP manufacturing systems
Responsibilities
Manage and supervise equipment installation and facility modifications; Analyze production and process issues to resolve them; Develop and train product and process knowledge; Investigate deviations using root cause analysis tools; Analyze Critical Process Parameters (CPPs) and process conditions; Participate in risk assessments and validation activities; Maintain interfaces with QA, QC, and Engineering Services.
Seniority
Senior, hands-on IC