Senior Validation Engineer Jobs in Georgetown, KY

ROLE SUMMARY

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.

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:

Leadership:

• 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

• 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.
• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field). Advanced degree preferred.
• 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
• 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

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