Sr. Manager, Manufacturing Engineering

Kindeva Drug Delivery; Lexington (KY); On-site; USD 120,000 - 150,000; Full time

Job summary

Kindeva Drug Delivery in Lexington seeks an Engineering Manager to lead high-impact capital projects at our manufacturing facility. Candidates should have over 15 years of engineering experience, particularly in pharmaceutical manufacturing.

The Engineering Manager will oversee capital expenditure programs and ensure compliance with CGMP and ISO standards while managing and mentoring a team of engineers. This role demands a strong background in automation technologies and project management.

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Qualifications

• 15+ years of experience in engineering roles focusing on capital projects in pharmaceutical manufacturing.
• Proven experience managing large-scale capital projects, including budgeting and scheduling.
• Strong knowledge of CGMP regulations, FDA requirements, and ISO cleanroom guidelines.

Responsibilities

• Develop and oversee a capital spend program aligned with strategic objectives.
• Lead the planning, design, and execution of capital projects ensuring quality standards.
• Drive implementation of automation technologies to improve manufacturing efficiency.

Skills

Project management

Problem-solving

Communication

Leadership

Education

Bachelor's degree in engineering

Advanced degree preferred

Tools

Project management software

Job description

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

Why Kindeva?

• Collaborative team culture
• Direct impact on patient care

The Impact You Will Make

The Engineering Manager will be responsible for building and administering a comprehensive capital spend program, managing high-impact capital projects, and leading the Engineering staff at the Kindeva Lexington manufacturing facility.

This role requires a strong background in CGMP manufacturing, automation, facility design, commissioning, and qualification to ISO cleanroom guidelines.

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.

Role Responsibilities

Capital Spend Program Management:

• 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.

Project Management:

• 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.
• Manage project teams, including internal staff, contractors, and vendors, to deliver projects on time and within scope.
• Oversee the commissioning, qualification, and validation of new equipment and facilities, ensuring compliance with regulatory standards.

Automation and Technology Integration:

• Drive the implementation of automation technologies to improve manufacturing efficiency, reduce downtime, and enhance product quality.
• Evaluate and select automation solutions that align with the company’s manufacturing needs and regulatory requirements.
• Ensure seamless integration of automation systems with existing processes and infrastructure.

Regulatory Compliance and Quality Assurance:

• Develop and enforce standard operating procedures (SOPs) and best practices for engineering activities.
• Support internal and external audits, providing documentation and addressing any findings related to engineering projects.

Team Leadership and Development:

• Manage and mentor a team of engineers and technical staff, fostering a culture of continuous improvement and professional growth.
• Identify training needs and provide opportunities for staff to enhance their skills and knowledge in relevant areas.
• Promote a safety-first culture by ensuring all engineering activities adhere to safety regulations and protocols.

Basic Qualifications

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field). Advanced degree preferred.
• 15+ years of experience in engineering roles, with a focus on capital projects in a pharmaceutical manufacturing environment.
• Proven experience in managing large-scale capital projects, including budgeting, scheduling, and resource allocation.
• Strong knowledge of CGMP regulations, FDA requirements, and ISO cleanroom guidelines.
• Background in automation technologies and their application in manufacturing processes.
• Excellent project management skills, including the ability to lead cross-functional teams and manage multiple projects simultaneously.
• Strong problem‑solving, decision-making, and leadership abilities.
• Effective communication and interpersonal skills.

Preferred Skills

• Certification in Project Management (PMP) or related disciplines.
• Experience with pharmaceutical facility design and construction.
• Familiarity with lean manufacturing principles and continuous improvement methodologies.
• Proficiency with project management software.

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.

Job Family B - Engineering - Manufacturing Engineering