Sr. Manager, Process Engineering (Capital Projects and Validation)
Core
Lead capital projects, critical process recipe developments, and oversee compliant operation of clinical packaging and assembly equipment for pharmaceutical and biotech customers.
Role type
Senior Manager, Process Engineering (Capital Projects and Validation)
Builds
Clinical packaging and assembly equipment, process recipes, and capital project deliverables
Domain
Pharmaceutical/Biotech manufacturing and clinical supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Capital project management, process development, GMP compliance, team leadership, Lean Six Sigma, cost reduction, technical documentation, equipment upgrades, resource allocation, continuous improvement
Preferred skills
Advanced engineering degree, Six Sigma certification, Lean Manufacturing experience, Practical Process Improvement (PPI)
Technologies
MS Office, spreadsheets
Responsibilities
Lead a team of Engineers providing technical oversight for packaging and assembly equipment; Manage engineering projects focused on design, optimization, and continuous improvement; Drive cost-saving initiatives through Lean Six Sigma; Oversee day-to-day execution of capital projects, repairs, and critical recipe developments; Partner with Sales on RFIs and RFPs for new projects; Serve as a technical subject matter expert during compliance audits, client visits, and facility tours; Mentor and develop engineering team members
Seniority
Senior, hands-on IC with supervisory responsibilities