Bay Area Capital Project Manager - GMP Manufacturing
Capital Project Manager - GMP Manufacturing
Role Overview
We are seeking a Capital Project Manager to lead facility, utility, and infrastructure projects within regulated manufacturing environments. This role is responsible for managing projects from early planning through construction, commissioning, and operational handoff. The position requires strong leadership, construction oversight, and experience working within GMP‑compliant facilities.
The Project Manager serves as the primary point of accountability for delivery, coordinating with engineering, construction, quality, validation, operations, and external partners to ensure successful project execution.
Key Responsibilities
Project Leadership
- Lead capital projects through all phases from authorization to completion
- Act as the primary decision maker and escalation point
- Align project goals with business, operational, and regulatory requirements
- Communicate progress, risks, and updates to leadership and stakeholders
Budget & Schedule Management
- Define and manage project scope, cost, and timeline
- Maintain accurate forecasts, track spend, and manage changes
- Identify risks early and implement mitigation plans
Design & Compliance
- Oversee development of engineering documents including requirements, design basis, and technical specifications
- Ensure facility designs align with GMP expectations for flow, separation, and cleanliness
- Coordinate design reviews with quality, validation, and operations teams
Construction Execution
- Manage on‑site construction activities, contractors, and vendors
- Oversee scheduling, sequencing, and field coordination
- Ensure adherence to safety standards and GMP construction practices
Startup & Validation
- Support transition from construction into commissioning and qualification
- Coordinate testing activities and readiness for validation
- Partner with validation teams to support IQ, OQ, and PQ efforts
- Deliver complete, audit‑ready documentation packages
Closeout & Turnover
- Ensure full project closeout including technical documentation and financial reporting
- Support operational readiness including training and system handover
- Capture lessons learned to improve future execution
Qualifications
- Bachelor's degree in Engineering, Construction Management, or related field
- Experience managing capital projects in GMP or regulated manufacturing environments
- Strong background in construction execution and contractor management
- Knowledge of commissioning, qualification, and validation processes
- Experience managing project cost, schedule, and risk
- Proven ability to lead cross‑functional teams
Core Strengths
- Project leadership and accountability
- Understanding of GMP environments and regulatory expectations
- Strong problem solving and decision making
- Effective communication with technical and executive stakeholders
- Ability to manage complex projects with multiple workstreams
FAQs
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