Job Title: Senior Project Engineer

Job Description

This role leads capital engineering projects, facility improvements, equipment installations, utility projects, and validation activities within a pharmaceutical manufacturing environment. The Senior Project Engineer owns projects from concept through completion, partnering with cross-functional teams to deliver safe, compliant, and efficient solutions while maintaining strict adherence to FDA regulations and current Good Manufacturing Practices (cGMP). This is a contract-to-hire opportunity within a growing organization that offers billable holiday time, paid time off, and significant room for professional growth.

Responsibilities

• Lead capital engineering projects from initial concept through detailed design, execution, and successful completion.
• Develop and manage project scopes, schedules, and budgets for CAPEX initiatives, ensuring alignment with business objectives.
• Coordinate and oversee contractors, vendors, and consultants, including contractor/vendor management and RFP or bid package development when needed.
• Plan and execute facility upgrades, construction activities, and utility system improvements in a medical manufacturing environment.
• Manage equipment installation projects, including commissioning, equipment qualification, and integration into existing operations.
• Support and lead validation activities, including IQ, OQ, and PQ, commissioning, and preparation of validation documentation.
• Ensure all projects comply with cGMP, FDA regulations, and internal quality standards throughout design, execution, and handover.
• Partner closely with Operations, Quality, Engineering, and Leadership teams to align project deliverables with manufacturing and business needs.
• Develop and maintain project documentation, including change controls, deviations, SOPs, and CAPA-related activities where applicable.
• Perform CAPEX budgeting and cost estimation, track project costs, and report on financial performance against budget.
• Identify and implement opportunities for Lean Manufacturing and continuous improvement within facilities and equipment-related projects.
• Support pharmaceutical packaging and sterile manufacturing projects when applicable, ensuring compliance with regulatory and customer requirements.

Essential Skills

• Experience in FDA-regulated manufacturing with a strong understanding of cGMP requirements.
• At least 4 years of Project Engineering experience in a manufacturing environment.
• Proven experience leading engineering projects from conception through implementation and completion.
• Hands-on capital project management experience, including budgeting, scheduling, scope development, and execution.
• Demonstrated experience with validation activities, including IQ, OQ, PQ, commissioning, and equipment qualification.
• Experience managing construction, facility upgrades, utility systems, and equipment installation projects.
• Strong contractor and vendor management skills, including coordination of external resources and services.
• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or a related discipline).

Work Environment

The role is based in a medical manufacturing environment that operates under strict pharmaceutical GMP and FDA-compliant standards. You will work closely with operations, quality, engineering, and leadership teams in a facility that supports pharmaceutical, biotechnology, medical device, life sciences, sterile manufacturing, and contract manufacturing activities. The environment is highly regulated, process-driven, and safety-focused, with an emphasis on documentation, validation, and continuous improvement. Standard engineering tools and project management practices are used to plan and execute capital projects, facility upgrades, construction, and equipment installations. The position is structured as contract-to-hire and offers billable holiday time, paid time off, and growth opportunities within a rapidly expanding organization.

This is a Contract to Hire position based out of Clinton, TN.

The pay range for this position is $48.08 - $57.69/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan