Sr. Project Engineer

Job Description

Job Summary

The Sr. Project Engineer leads capital, construction, utility, process improvement, and validation projects from concept through completion, ensuring they are delivered on time, within budget, and in compliance with quality, safety, cGMP, and company standards. This hands-on role partners with cross-functional teams to define project requirements, develop implementation plans, manage contractors and vendors, oversee budgets and schedules, and drive project execution. The position is responsible for construction management activities including scope development, bid and RFP processes, design reviews, value engineering, and cost control. Additionally, the Sr. Project Engineer supports equipment and facility validation efforts by coordinating IQ/OQ/PQ activities, authoring validation documentation, managing change controls, CAPAs, and deviations, and ensuring successful commissioning of new or modified manufacturing systems.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

Project Planning & Execution

• Lead capital, construction, utility, and process improvement projects from concept through completion, ensuring alignment with scope, schedule, budget, and business objectives.
• Develop project plans, including scope, requirements, resources, schedules, cost estimates, risk mitigation strategies, and communication plans.
• Monitor project progress, coordinate critical-path activities, evaluate operational impacts, and provide project status reporting to stakeholders.

Engineering Design, Construction, and Vendor Management

• Define project specifications, equipment requirements, and technical solutions while preparing scopes of work, feasibility studies, and engineering documentation.
• Manage the full construction lifecycle, including RFP development, bid evaluations, contractor and consultant selection, design reviews, approvals, and commissioning activities.
• Ensure designs, plans, and facility modifications meet operational needs, building standards, and code requirements while applying value engineering principles.

Validation, Quality, & Regulatory Compliance

• Lead validation activities for equipment, facilities, and utilities, including protocol development, execution, issue resolution, commissioning, and IQ/OQ/PQ documentation.
• Develop and maintain SOPs and quality documentation while supporting CAPAs, deviations, change controls, and continuous compliance initiatives.
• Ensure adherence to cGMP requirements, safety standards, customer expectations, and applicable regulatory requirements.

Financial Management, Leadership & Stakeholder Collaboration

• Manage project budgets, CAPEX requests, expenditures, contracts, cash flow, and cost-benefit analyses to achieve financial targets.
• Partner with operations, quality, engineering, procurement, and leadership teams to gather requirements, prioritize project needs, and support strategic business goals.
• Provide day-to-day project leadership, facilitate stakeholder communication, and drive successful project execution in a fast-paced manufacturing environment.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Electrical, or related engineering discipline) required.
• Minimum 4 years of engineering experience in project planning, project management, capital projects, construction, facilities, utilities, or manufacturing environments.
• Previous experience in pharmaceutical, biotechnology, life sciences, sterile manufacturing, or other regulated industries is required for consideration.
• Experience in a pharmaceutical cGMP manufacturing, packaging, OSD, or sterile setting required.