6316 - Capital Project Manager – GMP Manufacturing & Construction / Project Manager

Verista, Inc.•Novato, CA

14h•Onsite

About The Position

The Capital Project Manager is responsible for the end‑to‑end delivery of capital projects within a GMP-regulated manufacturing environment, from project initiation through commissioning, qualification, and handover. This role requires hands-on construction management capability, strong cross‑functional leadership, and demonstrated experience delivering manufacturing, utilities, and infrastructure projects in compliance with GMP, quality, and regulatory requirements. The Project Manager is accountable for scope, schedule, cost, quality, safety, and risk, and serves as the primary interface between Engineering, Construction, Quality, Validation, Operations, and external partners.

Requirements

Bachelor’s degree in Engineering, Construction Management, or related field
Significant experience delivering capital projects in GMP manufacturing environments
Strong construction execution and contractor management background
Demonstrated knowledge of: GMP facility design and construction practices, Commissioning and qualification processes, Capital cost control, forecasting, and scheduling
Proven ability to lead cross‑functional teams in regulated environments

Responsibilities

Lead capital projects in accordance with enterprise capital governance and phase‑gate requirements
Act as single point of accountability for project execution, decision-making, and escalation
Align project objectives with business needs, operational readiness, and regulatory expectations
Provide clear and proactive communication to senior leadership and stakeholders
Define and manage project scope, ensuring alignment with approved business requirements
Develop, maintain, and control integrated cost and schedule baselines
Lead change management, trend analysis, and forecast‑at‑completion reporting
Ensure timely identification and mitigation of project risks and constraints
Oversee development and approval of URS, Basis of Design, specifications, and drawings
Ensure GMP design principles are embedded (material/personnel flow, segregation, cleanability)
Facilitate GMP and constructability design reviews with Quality and Operations
Ensure documentation supports validation, regulatory inspection, and lifecycle management
Lead construction planning and execution, including site logistics, sequencing, and safety
Manage contractors, CM firms, and vendors to ensure efficient and compliant delivery
Oversee daily/weekly construction progress, field change control, and issue resolution
Enforce GMP construction controls: segregation, cleanliness, and controlled turnover
Ensure structured system turnover from construction to commissioning
Coordinate commissioning activities to support qualification readiness
Partner with Validation and Quality to support IQ/OQ/PQ execution
Issue complete, audit‑ready turnover packages to Operations and Quality
Ensure alignment with site change control and regulatory impact assessment requirements
Support regulatory filings, inspections, and audits as required
Maintain project documentation in a state of inspection readiness
Deliver complete project closeout, including financial, technical, and regulatory documentation
Support training, SOP updates, asset capitalization, and maintenance handover
Capture and communicate lessons learned to improve future project delivery