Sr Engineer
Core
Independently provides and directs characterization of process optimization strategies and troubleshooting of operational issues in operations, manufacturing, pilot plant, or capital projects environments.
Role type
Senior Engineering Specialist (Pharma/Biotech Manufacturing)
Builds
Major system modifications, experiments, and capital projects for pharmaceutical and biotechnology clients
Domain
Pharmaceutical and biotechnology manufacturing
Required skills
Advanced engineering principles, process optimization, troubleshooting, engineering policy development, staff supervision, cross-functional collaboration, technical writing, project management, cGMP knowledge, equipment assessment, risk assessment, change control, CAPA management, vendor management
Preferred skills
Regulated pharma/biotech manufacturing experience, equipment failure evaluation, technical report preparation, FDA commitment support, purification/fermentation knowledge, field presence for equipment inspection
Technologies
GLP/GMP standards, engineering drawing review, vendor documentation, calibration records, historical performance data analysis
Responsibilities
Develop new and improved engineering techniques and procedures; Develop engineering policies affecting multiple organizational units; Supervise and review work of engineers, associates, and technicians; Apply advanced engineering techniques to complex assignments; Coordinate work of consultants and engineering firms; Conduct technical assessments of equipment in manufacturing environments; Manage project budgets and lifecycles
Seniority
Senior, hands-on IC with leadership responsibilities
