Director of Engineering

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 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

Responsibilities:

Engineering, Maintenance & Validation Leadership 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. Client Portfolio & Business Integration 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. People Leadership & Development Develop and coach direct reports across engineering and client management functions.

Basic Qualifications:

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.

Preferred Qualifications:

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.

Physical Requirements:

Position requires the ability to sit and/or stand for extended periods and to work in a variety of settings, including office areas, manufacturing areas, and warehouse etc. Must be able to walk to and access all work areas. Routinely climbing stairs is necessary. Use of eye protection, gloves, and other PPE is required. Non-Standard Work Schedule /

Travel or Environment Requirements:

Position requires regular onsite attendance - responsibilities for this position cannot be performed on a remote or telecommute basis. Must have the ability to simultaneously multi-task across multiple capabilities, functions, and manage competing priorities, including performing site and functional responsibilities, frequent e-mail and phone communications, and attending multiple meetings and conference calls.

Note:

these activities may not be time-bound to core hours or presence at the site. Must have the ability to effectively manage strict production, time, and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays. #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. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!