Project Engineer / Sr. Project Engineer

A brief overview

The Project Engineer is responsible for the planning, design, execution, and implementation of capital projects related to manufacturing operations, facilities, utilities, and infrastructure within a GMP-regulated environment. The role manages small to moderate complexity projects and provides engineering support for larger capital initiatives.

The Project Engineer collaborates with cross-functional teams to develop project scopes, coordinate technical activities, oversee contractors and vendors, and ensure projects are completed safely, on schedule, within budget, and in compliance with regulatory, quality, and company requirements. The position contributes to equipment installations, facility modifications, process improvements, and operational excellence initiatives that support manufacturing growth and reliability.

What you will do

• Execute capital projects and engineering initiatives from planning through commissioning and turnover while supporting project objectives related to scope, schedule, budget, and quality.
• Develop project documentation including scopes of work, cost estimates, schedules, risk assessments, engineering specifications, and procurement packages.
• Coordinate engineering, operations, validation, maintenance, EHS, quality, contractors, and vendors to ensure successful project execution.
• Manage facility modifications, capacity expansion projects, equipment installations, and infrastructure upgrades supporting manufacturing growth.
• Prepare and review engineering deliverables including PFDs, P&IDs, layouts, equipment specifications, construction packages, and commissioning documentation.
• Lead contractor selection, bid evaluations, procurement activities, vendor oversight, and construction management efforts.
• Identify and implement process, equipment, automation, and operational improvements that increase safety, reliability, capacity, and efficiency.
• Track project progress, maintain project documentation, and provide routine status updates to project stakeholders and management.
• Support audits, inspections, change controls, deviations, and regulatory compliance activities related to engineering projects.

Qualifications

• Bachelor's degree in engineering or related field
• 4+ years engineering experience within pharmaceutical, biotechnology, chemical, or regulated manufacturing environments
• 1+ year capital project management and project execution experience
• cGMP facility, utility, and manufacturing equipment projects
• Facility expansions, automation, or process optimization projects (preferred)
• Capital project planning, budgeting, scheduling, and execution
• Project management methodologies and lifecycle management
• cGMP, GDP, GEP, and quality system requirements
• Pharmaceutical manufacturing processes, equipment, and utilities
• Engineering design standards, ASTM, ASME BPE, and applicable codes
• Construction management and contractor oversight
• Risk management and project mitigation planning
• Technical writing, specifications, reports, SOPs, and project documentation
• Microsoft Office Suite and project scheduling software (e.g., MS Project, Primavera)
• Ability to effectively communicate with stakeholders at all levels
• Ability to organize, prioritize, and manage multiple projects simultaneously
• Strong analytical, troubleshooting, and problem-solving abilities
• PMP, CAPM, or equivalent project management certification (preferred)