Job Description

Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

Our Work Matters
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.

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.

Basic Qualifications:
• 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.

Preferred 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.
Physical Requirements:
• Employees are required to follow all cGMP and safety procedures.
• Must wear all required PPE and perform assigned work in a safe manner.
• Must use proper lifting techniques and be aware of hazards in the environment.
• Must occasionally lift and/or move up to 20 pounds.

#LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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