Assoc Director, Manufacturing Engineering Lead - Downstream
Core
Lead the Manufacturing Engineering function to ensure the reliability, safety, and compliance of biopharmaceutical manufacturing process equipment and cGxP warehouse technologies.
Role type
Senior management engineering leader (biopharma manufacturing)
Builds
Manufacturing process equipment and validated warehouse systems
Domain
Biopharmaceutical manufacturing and regulated operations
Required skills
Biopharmaceutical manufacturing operations, GMP validation, cGMP/GLP/ISO compliance, regulatory audit defense, capital budgeting, cross-functional leadership, team development, equipment reliability management, operational strategy, crisis management
Preferred skills
Distributed control systems, PLCs, P&IDs, Lean Six Sigma, continuous improvement, contract management, multi-use facility support, strategic planning, resource management
Technologies
Distributed control systems, PLCs, P&IDs
Responsibilities
Lead and develop the Manufacturing Engineering function and team; Ensure equipment reliability, safety, and compliance; Establish departmental goals and metrics; Represent engineering in site leadership discussions; Lead validation strategy and lifecycle management; Defend engineering programs during regulatory audits; Manage operating and capital forecasts; Prioritize continuous-improvement initiatives; Provide technical direction during critical equipment issues; Coach and develop engineering employees
Seniority
Senior, hands-on IC
