Project Engineer

Description

The Project Engineer is responsible for providing engineering and technical leadership for equipment and infrastructure projects within a pharmaceutical manufacturing environment. This role supports the planning, design, execution, and closeout of engineering projects related to process equipment, utilities, facilities, and manufacturing systems.

The Project Engineer works cross-functionally with MS&T, Operations, Quality, Validation, Maintenance, EHS, and Supply Chain to ensure projects are technically sound, compliant with cGMP requirements, delivered safely, and completed on schedule and within budget.

Requirements

Engineering & Technical Execution

• Develop technical project scopes, equipment specifications, and engineering documentation.
• Prepare and review User Requirement Specifications (URS), functional/design specifications, and bid packages.
• Review P&IDs, equipment layouts, and vendor submittals to ensure alignment with process and site standards.
• Review and provide feedback on vendor RFIs; coordinate responses with cross-functional team members to ensure alignment. 
• Provide engineering oversight during equipment fabrication, installation, commissioning, and startup.
• Support FAT/SAT, commissioning activities, and validation efforts (IQ/OQ/PQ).
• Ensure compliance with cGMP, quality standards, and environmental health & safety (EHS) requirements.

Project Coordination

• Support development and maintenance of project schedules, budgets, and resource plans.
• Coordinate cross-functional activities to ensure timely completion of deliverables.
• Track project progress and communicate updates to stakeholders and leadership.
• Assist in risk identification, impact assessment, and development of mitigation strategies.
• Support change control processes and ensure proper documentation throughout the project lifecycle.

Vendor & Contractor Support

• Assist in development of RFPs and technical bid evaluations.
• Review vendor deliverables to confirm compliance with project requirements.
• Assist with coordination of vendor activities during equipment installation and startup.
• Review invoices against scope completion and project milestones.

Documentation & Continuous Improvement

• Maintain accurate and complete engineering documentation.
• Support continuous improvement initiatives within engineering, project management, and manufacturing operations.
• Participate in audit readiness activities and regulatory inspections as needed.
• Other duties as assigned.

Required Experience

• 5–7 years of engineering experience within pharmaceutical, biotech, or other regulated manufacturing environments.
• Experience supporting capital projects and equipment installations.
• Working knowledge of pharmaceutical manufacturing processes and GMP requirements.
• Understanding of engineering documentation including URS, construction documents, P&IDs, process flow diagrams, and equipment and systems specifications.
• Familiarity with validation lifecycle concepts (IQ/OQ/PQ/PV).

Technical Skills

• Proficiency in MS Office (MS Project, Excel, Word, and PowerPoint), Smartsheet, Autodesk 2D and 3D Software.
• Experience with document management systems such as SharePoint, OneDrive, or similar platforms.
• Experience with contractor document management systems such as Procore or BIM 360.
• Ability to interpret construction and engineering drawings, and technical documents.

Education & Certifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline).
• PE license or EIT certification preferred.
• PMP certification a plus but not required.

Key Attributes

• Excellent written and oral communication skills 
• Strong organizational skills
• Strong attention to detail
• Exhibits the highest level of reasoned judgment, discretion, and integrity. Integrity is our defining characteristic at Phlow
• Collaborates with others to achieve shared objectives. At Phlow, we are focused on working together, accepting feedback, and making it about results
• Ability to thrive in a fast-moving, continuous learning environment; iterating and learning as a team
• Active listener with a curious and open mind
• Steadfastly pursues excellence in execution
• Exhibits high regard for quality assurance and safety
• Servant leader

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 5% travel with occasional increase in travel demands based on business needs