475 Project Manager jobs in Lafayette,CA

Bachelor's degree in Engineering (Mechanical, Chemical, or Civil), Construction Management, Architecture, or a related scientific field.
PMP (Project Management Professional) certification required.
3-5 years of project management experience in complex technical construction.
2+ years of specific experience in Life Sciences, Biotech, or Pharmaceutical environments.
GMP facility capital projects ($1M–$25M+), including cleanroom build-outs (ISO 5–8), laboratory renovations, and critical infrastructure (validated HVAC, WFI/RO high-purity water, and EMS).
Expertise in overseeing the technical integration of manufacturing skids, analytical instrumentation, and specialized containment areas (e.g., BSL-2/3).
Deep understanding of FDA (21 CFR Part 211) and EMA regulatory requirements.
Experience interfacing with local authorities, including zoning and specialized fire/safety code officials for hazardous material storage.
Validation & Commissioning: Mastery of the V-Model approach, including IQ/OQ/PQ protocols and Turnover Packages (TOP).
Quality Management Systems (QMS): Direct experience managing Change Controls , Deviations, and CAPAs within a regulated project lifecycle.
Scheduling & Cost Control: Proficiency in MS Project or Primavera P6; expertise in budget forecasting and mitigating \"scope creep\" in highly regulated environments.
Risk Management: Ability to perform FMEA (Failure Mode and Effects Analysis) to protect product integrity during construction.
Cleanroom Standards: In-depth knowledge of ISO 14644 standards and Grade A–D operational requirements.
Operational Workflows: Understanding of unidirectional flow for personnel, material, and waste to prevent cross-contamination.
Technical Skills: Proficiency in BIM/VDC platforms (Autodesk Construction Cloud, Procore) and document control for audit-ready project files.
Critical Decision Making: Ability to assess if a construction delay or field change impacts the validated state of the facility.
Process Improvement: Applying \"Lean Construction\" or specialized methodologies to minimize downtime during facility shutdowns.