Project Engineer, Quality Engineering

The Project Engineer is responsible for managing facility, utility, manufacturing equipment, packaging equipment, and site-improvement projects within a sterile injectable manufacturing environment. This hands‑on role leads assigned projects from initial scope development through design, procurement, installation, commissioning, qualification, startup, turnover, and closeout. The Project Engineer also supports equipment reliability, site drawings, water‑room activities, fire‑protection systems, environmental monitoring system reporting, pest‑control follow‑up, and other facility and compliance programs.

• Manage assigned facility, utility, manufacturing equipment, packaging equipment, and site‑improvement projects through design, procurement, installation, commissioning, qualification, startup, turnover, and closeout.
• Develop project scopes, user requirements, equipment specifications, budgets, schedules, risk assessments, execution plans, capital justifications, and acceptance criteria.
• Coordinate contractors, equipment manufacturers, engineering firms, construction trades, qualification providers, and other third parties to ensure projects are completed safely, compliantly, on schedule, and within budget.
• Lead production line equipment installation and qualification projects in partnership with Packaging, Quality Assurance, Validation, Maintenance, equipment manufacturers, and third‑party service providers.
• Perform or coordinate site surveys, constructability reviews, installation verification, equipment and utility walkdowns, functional testing, punch‑list management, startup support, and final operational turnover.
• Create, revise, and maintain accurate AutoCAD site drawings, including facility layouts, equipment layouts, utility drawings, P&IDs, life‑safety drawings, construction drawings, redlines, and final as‑built documentation.
• Provide day‑to‑day engineering oversight for the site water room in coordination with the Water Systems Subject Matter Expert and cross‑functional site teams.
• Serve as the Facilities and Engineering point of contact for assigned facility and compliance programs, including fire‑protection systems, daily Environmental Monitoring System reporting, pest‑control report review, inspections, service‑provider coordination, corrective‑action tracking, and escalation of abnormal conditions.

• 2–7 years of progressively responsible engineering, project engineering, facilities engineering, manufacturing engineering, or capital‑project experience.
• Experience creating, revising, and maintaining site drawings using AutoCAD required.
• Experience with in pharmaceutical, biotechnology, sterile manufacturing, medical‑device, or another highly regulated manufacturing environment required; direct sterile injectable manufacturing experience strongly preferred.
• Hands‑on experience supporting or leading equipment or facility installation, commissioning, startup, troubleshooting, and project‑execution activities required.
• Experience managing project scope, schedules, budgets, vendors, contractors, field activities, technical documentation, and cross‑functional deliverables required.
• Experience with production line equipment, pharmaceutical water systems, critical utilities, clean rooms, HVAC, environmental monitoring systems, fire‑protection systems, or other regulated facility systems preferred.

• Bachelor’s degree in Mechanical, Electrical, Chemical, Industrial, Manufacturing, Biomedical, or a closely related engineering discipline required.

• Strong project‑management skills with the ability to manage scope, schedule, cost, safety, quality, risk, resources, and stakeholder expectations.
• Strong understanding of equipment installation, commissioning, startup, troubleshooting, qualification support, turnover, and project closeout.
• Working knowledge of manufacturing equipment, packaging systems, clean rooms, HVAC, water systems, plant utilities, critical utilities, facility infrastructure, and life‑safety systems.
• Proficiency with AutoCAD and the ability to create, revise, interpret, organize, and maintain engineering drawings.
• Abili…