Manager, Engineering
Core
Lead engineering resources and cross-functional teams to develop, execute, and support medium to large capital and maintenance projects ($50K–$60M) for biological production systems, critical utilities, and infrastructure at a biotech facility.
Role type
Senior Engineering Manager (Capital & Maintenance)
Builds
Biological production systems, critical utilities, and related infrastructure supporting fermentation, downstream processing, containment, and sterile filling.
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Engineering project leadership, capital planning, asset reliability, root cause analysis, regulatory compliance (FDA/USDA/EU), technical documentation, team management, problem-solving
Preferred skills
Lean Six Sigma, CAD, Bluebeam, CappApp, maintenance strategy development
Technologies
CMMS, CAD, Bluebeam, CappApp
Responsibilities
Lead engineering activities for capital and maintenance projects from concept to completion; Develop and manage project scopes, budgets, and schedules; Partner with operations, quality, and finance to execute initiatives; Oversee design, commissioning, qualification, and validation of production systems; Lead and coach engineering staff and contractors; Ensure compliance with safety, environmental, and quality requirements; Manage quality change requests and safety assessments; Develop and approve engineering documentation (URS, FRS, SOPs); Support project closeout and turnover to operations.
Seniority
Senior, hands-on IC with leadership responsibilities
