Senior Project Engineer I

Kindeva•Lexington, KY

2d•Onsite

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. As a Senior Project Engineer, you will be responsible for overseeing and driving multiple Engineering projects, including major facility and equipment investments, to successful completion. This role ensures projects are delivered on time, within scope, and within budget while maintaining compliance with regulatory, safety, and operational requirements. The Senior Project Engineer I leverages Smartsheets to track project timelines, resources, deliverables, and risks, while ensuring effective communication with cross-functional teams, stakeholders, contractors, and site leadership.

Requirements

Bachelor’s degree in Business, Project Management, Engineering, or a related field.
PMP, Scrum, or similar project management certification is a plus.
Minimum of five (5) years of project management experience with a proven track record of successfully managing complex projects.
Strong hands-on experience using Smartsheets for project management and collaboration.
Excellent organizational, problem-solving, and analytical skills.
Strong communication and interpersonal skills, with the ability to interact effectively with diverse stakeholders and teams.
Qualified to work with controlled substances.

Nice To Haves

Minimum of five (5) years of previous work experience in a related field.
Working knowledge of cGMP (current Good Manufacturing Practices), GAMP5 (Good Automated Manufacturing Practice), and regulatory requirements.
Experience working with nasal spray products and devices or related drug-delivery devices.
Technical writing experience, including SOPs (Standard Operating Procedures), maintenance, preventive maintenance plans, user requirement specifications, and vendor requests for proposal.

Responsibilities

Project Planning & Execution
Develop and manage detailed project plans using Smartsheets, including timelines, resource allocation, and budget tracking.
Monitor project performance and progress, ensuring adherence to project timelines and scope.
Adjust project plans as needed to address risks or challenges.
Stakeholder Management
Regularly update stakeholders and leadership on project status, key deliverables, and potential roadblocks.
Facilitate communication between project teams and other departments to ensure project alignment and successful outcomes.
Act as the main point of contact for project inquiries, ensuring effective communication throughout all project phases - accuracy, compliance, and audit
Contractor Management
Ensure compliance with regulatory and safety standards.
Manage the integration of utilities and facility systems with new equipment.
Oversee contractors and vendors to maintain timelines and budget adherence.
Mitigate risks associated with large-scale construction and equipment installation.
Risk & Issue Management
Identify potential project risks and issues and proactively develop mitigation strategies.
Resolve project-related problems or conflicts efficiently while maintaining positive team morale.
Resource Management
Coordinate the allocation and utilization of Engineering and Validation resources across multiple projects.
Ensure resource availability and manage project team dynamics.
Budget Management
Track and monitor project budgets, ensuring all activities stay within approved financial limits.
Work with Financial teams to report on project costs and variances in the ERP system (Dynamics 365).
Smartsheets Expertise
Create, update, and maintain Smartsheets templates and dashboards for tracking and reporting project progress.
Train team members and stakeholders on effective Smartsheets usage, ensuring efficient collaboration and reporting.