Manager, PX, GWE, Manufacturing & Packaging Lead Engineer
Core
Provide technical leadership and engineering oversight for 24/7 critical maintenance services supporting R&D manufacturing and packaging operations in a regulated pharmaceutical environment.
Role type
Manager, Manufacturing & Packaging Lead Engineer
Builds
Reliable production support systems, critical assets, and continuous improvement initiatives for small molecule clinical manufacturing and packaging.
Domain
Pharmaceutical manufacturing / GxP regulated environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Asset lifecycle management, cGMP compliance, preventive and predictive maintenance strategies, capital project execution, root cause analysis, vendor performance management, Lean/Six Sigma methodologies, fiscal management, CMMS proficiency
Preferred skills
Packaging systems expertise, automation and control systems (PLC, SCADA), reliability engineering programs, advanced degree (MS or MBA)
Technologies
CMMS, Microsoft Office Suite, PLC, SCADA
Responsibilities
Lead asset lifecycle management including design, installation, commissioning, and obsolescence planning; Partner with manufacturing teams to ensure equipment reliability and uptime; Drive continuous improvement and predictive maintenance strategies; Lead and support capital projects from scope development to commissioning; Ensure compliance with cGMP, EHS, and Quality standards; Manage and develop a team of contractors; Oversee vendor performance and service delivery; Support Business Continuity and Crisis Management.
Seniority
Manager, hands-on technical leadership
