Senior Project Engineer

📍 Clinton, TN | Full-time

At least one year of Pharmaceutical GMP is required for consideration.

📝Summary of the Role:

The 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 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.
• Your Expectations:

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.

🎓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.
• Experience leading cross-functional projects from concept through implementation, including scope development, budgeting, scheduling, contractor management, and project execution.
• 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.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) required; experience with project management and scheduling tools preferred.
• 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.
• Previous experience in pharmaceutical, biotechnology, life sciences, sterile manufacturing, or other regulated industries is required for consideration.

🤝Why Choose Tjoapack?

At Tjoapack, we believe our employees are at the center of our success. We are committed to creating a supportive, employee-focused culture that encourages teamwork, growth, curiosity, and continuous learning. Our teams work collaboratively every day to help ensure life-changing medications reach patients around the world safely and on time.

We offer competitive compensation and a comprehensive total rewards package designed to support both your personal and professional wellbeing.

At Tjoapack, you'll find opportunities to learn, take on new challenges, and make a direct impact. We are a team that supports one another, works hard together, and moves toward success together. Apply to work with us today!

🎯Selection Process:

Submit your Application à Complete a Phone Screening with Tjoapack's Recruiter à Complete your Hiring Manager Interview à Complete an Onsite Interview à 15 Minute Site Leader Interview via Teams