Senior Project Engineer I

Responsibilities

• 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.
• 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.
• 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.
• Identify potential project risks and issues and proactively develop mitigation strategies.
• Resolve project-related problems or conflicts efficiently while maintaining positive team morale.
• Cookordinate the allocation and utilization of Engineering and Validation resources across multiple projects.
• Ensure resource availability and manage project team dynamics.
• 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).
• 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.

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.

Qualifications

• 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.