Engineering Manager

Job Description

Job Description

Kindeva Drug Delivery is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal / Intradermal Patch, and Nasal Spray Technologies.

The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth.

We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.

MUST HAVES : Bachelor’s degree in engineering, 8+ years’ experience in an engineering role, strong knowledge of; CGMP regulations, FDA requirements, experience with managing large-scale capital projects, automation, facility design, and commissioning and qualification of ISO cleanroom guidelines.

Relocation Assistance Offered

Compensation and Benefits : This is a full-time, salaried position with a competitive compensation package including benefits such as health insurance, 401(k) plan, paid time off, and opportunities for professional development.

Job Summary : If you are ready to work for a purpose, the Engineering Manager will be responsible for building and administering a comprehensive capital spend program, managing high-impact capital projects, and leadership of Engineering staff at the Kindeva Lexington manufacturing facility.

The Engineering Manager will ensure the successful execution of capital projects that support the company's strategic goals, driving efficiency, compliance, and innovation in facility operations

Position Responsibilities :

• Develop, implement, and oversee a capital spend program, aligning with the company’s strategic objectives and budgetary constraints.
• Monitor capital expenditures and ensure efficient allocation of resources across multiple projects.
• Provide regular updates to senior management on capital spend, project status, and potential risks or opportunities.
• Lead the planning, design, and execution of high-impact capital projects, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with cross-functional teams, including manufacturing, quality, and regulatory, to ensure projects meet CGMP and ISO requirements.
• Drive the implementation of automation technologies to improve manufacturing efficiency, reduce downtime, and enhance product quality.
• Oversee the commissioning, qualification, and validation of new equipment and facilities, ensuring compliance with regulatory standards.

Requirements :

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field). Advanced degree preferred.
• Proven experience in managing large-scale capital projects, including budgeting, scheduling, and resource allocation.
• Background in automation technologies and their application in manufacturing processes
• Excellent project management skills.
• Strong problem-solving, decision-making, and leadership abilities.
• Effective communication and interpersonal skills.

EEOC Statement :

Kindeva Drug Delivery / Summit Biosciences is an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other legally protected status.

We are committed to creating a diverse and inclusive workplace and encourage individuals of all backgrounds to apply.