Sr. Project Engineer

Alcami Corporation•Clinton, TN

25d•Onsite

About The Position

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.

Requirements

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.
Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) required
Strong technical, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
Excellent communication, presentation, and stakeholder management skills with the ability to collaborate effectively across all levels of the organization.

Nice To Haves

Demonstrated experience managing capital improvement, facility, equipment, utility, or construction projects within regulated manufacturing environments preferred.
Experience supporting validation activities, including commissioning, IQ/OQ/PQ execution, and validation documentation preferred.
Experience preparing project cost estimates, CAPEX justifications, bid evaluations, and financial tracking for engineering projects.
experience with project management and scheduling tools preferred.

Responsibilities

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.
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.
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.
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.