Director of Engineering

KindevaLexington, KY
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 Director of Engineering, you will lead Engineering, Maintenance, and Validation functions while also serving as the primary operations, portfolio, and business management point of contact for an assigned portfolio of clients and Kindeva’s Commercial/Business Development leadership. This role integrates technical leadership with client relationship management, ensuring operational excellence and client satisfaction.

Requirements

  • Bachelor of Science (BS) degree in a science-related field, engineering, or equivalent experience.
  • BS/MS in Engineering or related field.
  • 10+ years in GMP manufacturing/engineering.
  • 3+ years in managing technical teams.
  • Hands-on experience in validation, equipment troubleshooting, and repair.
  • Strong understanding of client relationship management in a CDMO environment.
  • Excellent communication, leadership, and organizational skills.
  • Physical ability to work across office and manufacturing environments, lift/move up to 25 pounds, and follow safety protocols.

Nice To Haves

  • M.B.A. preferred
  • 15+ years cGMP experience in biotech, pharmaceutical, or biopharmaceutical manufacturing environment, ideally pre-clinical phases through commercial, and/or equivalent amount of experience managing commercial operations or client portfolio management roles.
  • 5 years of experience with FDA/EU and participation in regulatory agency inspections, preferred.
  • Strong leadership, high level of personal/departmental accountability, and responsibility.

Responsibilities

  • Lead Engineering, Maintenance, and Validation teams in support of manufacturing operations.
  • Oversee plant commissioning, equipment procurement, and validation activities.
  • Ensure completion of equipment qualification and cleaning validation.
  • Maintain responsibility for the qualification and ongoing maintenance of production areas and equipment.
  • Lead Client Portfolio & Relationship Management actions and serve as the primary site operations point of contact to the client.
  • Ensure orchestrated client engagement models are established and executed.
  • Act as liaison with the Kindeva Commercial team and connect site functions with business development.
  • Champion operational engagement and provide leadership for client-facing routines and performance reviews.
  • Develop and coach direct reports across engineering and client management functions.
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