Project Engineer

Project Engineer

The Project Engineer is responsible for supporting the planning, design, execution, and commissioning of capital projects associated with the construction, startup, and expansion of a new pharmaceutical manufacturing facility. This position will work closely with Facilities, Engineering, Manufacturing, Quality, Validation, and external contractors to ensure projects are completed safely, on schedule, within budget, and in compliance with applicable regulatory requirements.

The Project Engineer will coordinate engineering activities throughout the project lifecycle, including conceptual design, procurement, construction oversight, equipment installation, commissioning, qualification support, and project closeout. This role requires strong technical knowledge, project management skills, and the ability to collaborate across multiple functional areas.

Areas of Responsibility

• Capital Project Execution
  • Support the planning and execution of capital engineering projects from concept through completion.
  • Hands-on management of packaging equipment relocation and new installation activities, including OEM vendor and Technician coordination, and issue resolution.
  • Assist in developing project scopes, schedules, budgets, and technical specifications.
  • Coordinate engineering activities with internal departments, architects, engineers, contractors, vendors, and equipment manufacturers.
  • Monitor project progress to ensure milestones are achieved on schedule and within budget.
  • Support equipment procurement activities, including technical evaluations, vendor selection, factory acceptance testing (FAT), and site acceptance testing (SAT).
  • Coordinate installation, startup, commissioning, and qualification activities for manufacturing equipment and facility systems.
  • Participate in design reviews to ensure compliance with operational, regulatory, and safety requirements.
  • Track project costs and support capital expenditure reporting.
  • Prepare project documentation including schedules, meeting minutes, status reports, risk assessments, and change documentation.
  • Support project closeout activities, including documentation turnover and lessons learned.
• Engineering & Technical Support
  • Collaborate with Operations, Maintenance, Validation, Quality, Manufacturing, and Process Engineering teams to support facility readiness.
  • Review engineering drawings, P&IDs, layouts, specifications, and construction documents.
  • Ensure engineering designs comply with applicable building codes, industry standards, and company engineering practices.
  • Assist in troubleshooting equipment and facility issues during startup and operational readiness.
  • Participate in continuous improvement initiatives to improve equipment reliability, project execution, and operational efficiency.
  • Install and or modify equipment as required.
• Quality & Regulatory Compliance
  • Ensure engineering projects comply with cGMP requirements and applicable regulatory standards, including FDA, EU GMP, ISO, and other relevant regulations.
  • Support Change Control, CAPA investigations, Risk Assessments, Validation protocols, and Engineering Change Notices (ECNs).
  • Maintain complete, accurate, and audit-ready engineering documentation.
  • Execute projects in accordance with company policies, SOPs, engineering standards, quality systems, and ethical business practices.
  • Maintain proper gowning and hygiene practices in accordance with cGMP requirements.
• Safety
  • Promote a safe work environment and ensure compliance with all company safety policies.
  • Participate in contractor safety oversight during construction activities.
  • Identify and mitigate project risks related to safety, quality, schedule, and cost.
  • Follow all required PPE and safety procedures.

Knowledge & Skills

• Knowledge of engineering design, construction, commissioning, and equipment installation.
• Strong hands-on fabrication, equipment installation, and controls experience.
• Understanding of pharmaceutical facility design and GMP manufacturing environments.
• Knowledge of project management principles and engineering documentation.
• Familiarity with construction methods and contractor management.
• Ability to read and interpret engineering drawings, P&IDs, equipment layouts, and technical specifications.
• Strong analytical and problem-solving skills.
• Excellent organizational and time management abilities.
• Strong written and verbal communication skills.
• Ability to manage multiple projects simultaneously.
• Proficient in Microsoft Office Suite and Microsoft Project or similar project management software.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Collaboration & Communication

• Build and maintain effective working relationships with Engineering, Operations, Quality, Validation, Maintenance, and external contractors.
• Communicate project status, risks, and schedule updates to project stakeholders and management.
• Support cross-functional teams to ensure successful project execution and facility readiness.
• Contribute to a collaborative environment that encourages continuous improvement and operational excellence.

Travel

• Travel between USPL facilities will be required to support engineering projects, equipment installations, commissioning activities, and cross-site collaboration.
• Occasional travel to vendor locations for Factory Acceptance Testing (FAT), training, or project meetings may also be required.

Other Responsibilities

• Work safely and responsibly to support an injury-free and incident-free workplace.
• Complete all required safety, GMP, and compliance training.
• Keep management informed of project progress, issues, and potential risks.
• Support equipment installations and project activities during off-hours or weekends when required to minimize operational impact.
• Perform other duties and special projects as assigned.

Requirements

• Education & Qualification: 3-7 years of engineering or project engineering experience in pharmaceutical, biotechnology, medical device, food, or other regulated manufacturing environments.
• Experience supporting capital projects and facility expansions preferred.
• Experience working with contractors, equipment vendors, and cross-functional project teams.
• Familiarity with commissioning, qualification, and validation activities is preferred.
• Experience with pharmaceutical manufacturing facilities or cleanroom environments is highly desirable.
• Physical Requirements: Ability to lift up to 50 pounds occasionally. Ability to walk construction sites and manufacturing areas for extended periods. Ability to climb ladders and access equipment when necessary. Ability to wear required personal protective equipment (PPE), including (but not limited to) safety glasses, hard hat, steel-toe shoes, hearing protection, gloves, and respiratory protection as required.
• Work Environment: This position is split between office and manufacturing/construction environments. The Project Engineer will routinely work within active construction sites, utility areas, laboratories, and GMP manufacturing spaces. Exposure to noise, dust, chemicals, and construction activities should be expected. Occasional evening, weekend, or extended work hours may be required to support project milestones and equipment installations.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.

Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment.

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