Sr. Director, Global Engineering

Kindeva Drug Delivery•Woodbury, MN

2d•Remote

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Sr. Director, Global Engineering leader responsible for harmonizing and improving engineering functions across a global network of manufacturing sites specializing in sterile injectable, inhalation, and transdermal advanced drug delivery. This role ensures operational excellence by developing and enforcing global engineering standards, improving processes to ensure industry standards are met, and helping to maintain GMP compliance across all sites. The leader will also play a critical role in driving innovation, supporting facility expansions, and ensuring seamless integration of engineering, validation, and automation capabilities that meet regulatory requirements and business needs.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field);
15+ years of progressive engineering leadership experience in GMP-regulated pharmaceutical or biotechnology environments, preferably with sterile injectables and/or advanced drug delivery technologies.
Proven track record in leading multi-site engineering organizations and executing large-scale capital projects.
In-depth knowledge of cGMP, FDA, EMA, and global validation standards.
Demonstrated experience developing and managing global engineering and validation standards, and capital governance frameworks.
Strong project management, budget control, and strategic planning capabilities.
Excellent communication and stakeholder management skills, including experience in presenting to executive leadership and regulatory agencies.
Ability to travel as required.

Responsibilities

Establish and manage global standards and governance frameworks for engineering practices, facility design, equipment selection, automation, and utility systems.
Ensure consistent and compliant practices for equipment, facility, utility, and computer system validation and qualification, in accordance with relevant global regulatory requirements.
Drive continuous improvement initiatives in facility design and engineering systems to support scalability, efficiency, and product lifecycle management.
Provide engineering support and technical direction for manufacturing operations, including equipment reliability, facility upgrades, and infrastructure maintenance.
Participate in engineering risk assessments and ensure engineering activities are aligned with quality and safety standards.
Ensure alignment and integration between site engineering teams and central/global engineering functions.
Partner closely with Manufacturing, Quality, Validation, Supply Chain, and IT to ensure seamless execution of engineering projects.
Serve as a senior technical representative in regulatory inspections and audits.
Mentor and develop a high-performing, globally dispersed engineering team.