Project Engineer

Position Summary

Contract Engineer. The resource will plan, coordinate, execute, and manage engineering projects related to pharmaceutical and biopharmaceutical manufacturing facilities, infrastructure, utilities, equipment installation, and facility expansions.
The Project Engineer will work closely with Engineering, Manufacturing, Quality Assurance, Quality Control, EHS, external consultants, contractors, and equipment vendors to ensure projects are completed safely, on schedule, within budget, and in compliance with applicable GMP, regulatory, and company requirements.

Essential Duties & Responsibilities

• Plan, coordinate, and execute engineering and capital improvement projects from conceptual design through construction, commissioning, qualification, and project closeout.
• Develop and review project scopes, technical specifications, User Requirement Specifications (URS), equipment specifications, and engineering drawings.
• Coordinate architectural, structural, mechanical, electrical, plumbing (MEP), HVAC, process utility, and other engineering design activities.
• Manage day-to-day project activities, including contractor coordination, vendor communications, construction progress, and technical issue resolution.
• Review engineering drawings, equipment submittals, technical proposals, construction documents, and contractor bids.
• Coordinate installation, testing, commissioning, and qualification activities for manufacturing equipment, facility systems, and critical utilities.
• Support projects involving HVAC, cleanrooms, purified water (PW), Water for Injection (WFI), clean steam, compressed air, nitrogen, chilled water, electrical systems, generators, and other critical utilities.
• Ensure project activities comply with applicable cGMP, FDA, OSHA, environmental, building codes, and company quality requirements.
• Coordinate with QA, Validation, Manufacturing, and Engineering teams to ensure proper documentation, change controls, and qualification requirements are addressed.
• Prepare project schedules, progress reports, meeting minutes, action item logs, and project documentation.
• Monitor project budgets, purchase requisitions, purchase orders, contractor invoices, and project expenditures.
• Identify project risks, technical challenges, schedule delays, and potential cost impacts; communicate issues proactively to management.
• Coordinate site inspections, construction activities, testing, and acceptance of completed work.
• Ensure proper turnover documentation, including as-built drawings, O&M manuals, equipment documentation, warranties, and commissioning records.
• Execute assigned duties on time and communicate project progress and potential delays to management and relevant stakeholders.
• Comply with all regulatory, corporate, safety, and Quality System policies.

Position Requirements and Qualifications

Education:

• Bachelor's degree in Mechanical, Electrical, Chemical, Industrial Engineering, or another relevant engineering discipline preferred; equivalent combination of education, technical training, and extensive relevant industry experience will also be considered. Candidates with significant hands-on engineering and project management experience may qualify in lieu of a bachelor's degree.
• Minimum of 2+ years of engineering or project engineering experience in pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
• Experience managing facility construction, manufacturing equipment installation, utilities, or capital improvement projects.
• Experience in biologics, sterile manufacturing, or pharmaceutical manufacturing environments is highly desirable.

Special Skills:

• Strong knowledge of pharmaceutical and biopharmaceutical manufacturing facilities, GMP requirements, and engineering practices.
• Experience with HVAC systems, cleanrooms, process utilities, electrical systems, equipment installation, and facility infrastructure.
• Ability to read and interpret architectural, structural, mechanical, electrical, plumbing, P&ID, and engineering drawings.
• Experience developing and reviewing URS, engineering specifications, technical proposals, and construction documents.
• Knowledge of commissioning, qualification, validation, IQ/OQ/PQ, and engineering change control processes.
• Experience coordinating engineering consultants, contractors, equipment suppliers, and construction teams.
• Familiarity with project management tools, including Microsoft Project, Excel, Word, and PowerPoint.
• Knowledge of AutoCAD, Revit, or other engineering design software is desirable.
• Ability to manage multiple projects simultaneously and prioritize competing assignments.
• Excellent written and verbal communication and interpersonal skills.