Project Engineer

Haag, a Salas O'Brien Company•Raleigh, NC

17d•Onsite

About The Position

The Project Engineer will support the execution of capital projects within regulated manufacturing environments, including pharmaceutical and life sciences facilities operating under cGMP requirements. This role focuses on coordinating and executing project activities within operating facilities, supporting system modifications, equipment installations, and process improvements. The candidate will work closely with engineering, operations, quality, validation, and external vendors to ensure projects are delivered in alignment with technical requirements, controlled documentation processes, and regulatory expectations. Candidates should have an understanding of how projects are implemented in regulated environments, including exposure to change control, validation activities, and documentation systems, and the impact these requirements have on project execution.

Requirements

Bachelor’s degree in Engineering (Chemical, Mechanical, or equivalent preferred)
Equivalent education and experience may be considered for candidates with significant experience supporting pharmaceutical, biotech, or other regulated manufacturing environments
0–5 years of experience supporting capital projects or project execution, preferably in: Pharmaceutical, biotech, or life sciences industries OR other regulated manufacturing environments (e.g., food & beverage, semiconductor, or cleanroom-based industries)
Candidates without direct pharmaceutical experience may be considered if they have relevant, transferable experience, such as: Equipment installation and commissioning, Process equipment or manufacturing systems projects, Clean utilities, HVAC systems, or facility infrastructure work, Project execution within operating facilities requiring coordination across multiple stakeholders
Candidates with more than 3 years of experience are expected to demonstrate either: Direct pharmaceutical / cGMP experience OR clearly transferable experience within regulated or highly controlled environments
Demonstrated experience supporting execution of capital projects, including coordination of scope, schedule, vendors, and project deliverables.
Experience developing and managing project documentation, including meeting notes, action tracking, and project deliverables aligned with execution requirements.
Working knowledge of process systems, utilities, and equipment within manufacturing or regulated environments.
Familiarity with regulated environments (cGMP or similar frameworks) and understanding of how project execution integrates with change control, validation, and documentation systems.
Experience coordinating with vendors, contractors, and internal teams to support project implementation.
Ability to support multiple projects and priorities in fast-paced environments.
Willingness to work across different project types and technical challenges.
Demonstrated ability to take ownership of deliverables and drive project tasks to completion.
Strong organizational and problem-solving skills with attention to detail.

Nice To Haves

Experience supporting capital projects within pharmaceutical or other regulated manufacturing environments
Experience with change control, deviation management, or CAPA processes
Experience supporting CQV or validation-related project activities
Experience with one or more of the following within regulated environments: Clean utilities, process equipment, or manufacturing systems, Maintenance programs, CMMS systems, or GMP-aligned maintenance practices
Prior experience working in pharmaceutical, biotech, life sciences, or adjacent regulated industries

Responsibilities

Support and execute capital projects within operating facilities or greenfield projects, including equipment installations, system modifications, expansions, and process improvements from scope development through implementation.
Coordinate project activities across engineering, operations, quality, validation, and vendor teams to ensure alignment with technical, schedule, and compliance requirements.
Participate in development and execution of project deliverables including scope definition, equipment selection, procurement support, and installation coordination.
Support implementation of projects in environments requiring change control, validation, and controlled documentation practices.
Contribute to projects involving process equipment, clean utilities, and manufacturing systems within existing operations and new installations.
Work independently while leveraging internal, client, and industry resources to deliver accurate and efficient solutions.
Build and maintain strong professional relationships with team members, clients, vendors, and contractors.
Coordinate across cross-functional teams to support project execution in regulated manufacturing environments and ensure alignment with operational and compliance requirements.
Maintain accurate and comprehensive project documentation, including design specifications, project execution plans, and progress reports.
Collect, track, and communicate project data including schedule updates, risks, and action items.
Develop and manage documentation in accordance with both engineering project processes (internal execution, tracking, and deliverables) and controlled documentation systems within regulated environments, including cGMP requirements, validation activities, and change control processes.
Communicate effectively with clients, contractors, and project teams regarding project scope, deliverables, risks, and compliance requirements, including engagement with stakeholders at technical, managerial, and executive levels.
Ensure timely and accurate transfer of information in environments requiring controlled documentation and coordination across multiple stakeholders.
Proactively identify and communicate issues, risks, and knowledge gaps, leveraging internal resources to support resolution and maintain project progress.
Support process and project improvement initiatives focused on efficiency, execution, and compliance within regulated environments.
Develop and implement practical solutions to project and system challenges, working cross-functionally to address client needs.
Contribute to a collaborative environment by generating ideas, supporting implementation of improvements, and helping teams adapt to changes within project execution environments.