Senior Engineering Manager

Kindeva Drug Delivery; Lexington (KY); On-site; USD 110,000 - 140,000; Full time

Job summary

Kindeva Drug Delivery in Lexington, Kentucky, is seeking an Engineering Manager responsible for overseeing capital spend programs and managing high-impact capital projects. The ideal candidate will have over 15 years of engineering experience in CGMP manufacturing, particularly in automation and facility design.

This role involves leading a team of engineers, ensuring efficient project execution, and enforcing regulatory compliance. Strong communication and project management skills are required. The position aims to drive efficiency and innovation in facility operations.

Qualifications

• 15+ years of engineering experience focused on capital projects in pharmaceutical manufacturing.
• Proven experience managing large-scale capital projects including budgeting and resource allocation.
• Strong knowledge of CGMP regulations and ISO cleanroom guidelines.

Responsibilities

• Develop and oversee a comprehensive capital spend program aligned with strategic objectives.
• Lead planning, design, and execution of high-impact capital projects while adhering to timelines.
• Drive implementation of automation technologies for efficiency and quality improvements.
• Manage and mentor a team of engineers fostering continuous improvement.

Skills

Engineering experience

Project management

CGMP regulations knowledge

Automation technologies

Leadership abilities

Education

Bachelor’s degree in engineering

Tools

Project management software

Job description

Role Summary

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

Requires a strong background in CGMP manufacturing, automation, facility design, commissioning, and qualification to ISO cleanroom guidelines. The Manager ensures the successful execution of capital projects supporting 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 that aligns with 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 manufacturing, quality, regulatory, and other cross‑functional teams 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 commissioning, qualification, and validation of new equipment and facilities, ensuring compliance with regulatory standards.
• Automation and Technology Integration:
  • Drive implementation of automation technologies to improve manufacturing efficiency, reduce downtime, and enhance product quality.
  • Evaluate and select automation solutions that align with 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 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 to enhance staff skills and knowledge.
  • 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 engineering experience with a focus on capital projects in a pharmaceutical manufacturing environment.
• Proven experience 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 and cross‑functional team leadership skills.
• Strong problem‑solving, decision‑making, and leadership abilities.
• Effective communication and interpersonal skills.

Preferred Skills

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

California residents should review our Notice for California Employees and Applicants before applying.

Covid‑19

Safety for our employees and communities is a key priority. Kindeva encourages everyone eligible to get vaccinated.

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.