Eli Lilly
healthcare
SeniorDirector-Process,Maintenance&AutomationEngineering
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“Senior Director - Process, Maintenance & Automation Engineering at Eli Lilly. Skills: Process Engineering, Automation, Maintenance Management, GMP Compliance, Regulatory Compliance. Provide strategic and operational leadership for Process Engineering, Automation, and Maintenance functions. Ensure reliability, compliance, and continuous performance of manufacturing equipment, control systems, and automated technologies”
Industry & Context.
Problem-solving skills; Troubleshooting; Deviation resolution
What They're Looking For.
Must Have
Bachelor's degree in Engineering (Chemical, Electrical, Mechanical, or equivalent), 10+ years of experience in engineering-related fields, 7+ years in manufacturing, preferably in pharmaceutical or other regulated industries, Demonstrated experience in process engineering, automation systems, and maintenance management in a GMP-regulated environment, Knowledge of pharmaceutical regulations including cGMPs, 21 CFR Part 11, and FDA Computer Systems regulations, Knowledge of Computer Systems Validation (CSV), Infrastructure Platform Qualification, and Software Quality practices, Knowledge of System Lifecycle management, software engineering, design principles, and infrastructure operations, Knowledge of process safety management principles, Effective leadership, teamwork, interpersonal, and communication skills, Excellent technical writing, negotiation, and presentation capabilities, Ability to work with minimal supervision, manage competing priorities, and drive results in a fast-paced, evolving environment, decision-making, problem-solving, and organisational skills, Ability to influence and develop self-starter with self-management skills
Nice to Have
Ideally bilingual — English and Dutch preferred
What You'll Do.
Provide strategic and operational leadership for Process Engineering
and Maintenance functions
and continuous performance of manufacturing equipment
and automated technologies
Champion next-generation manufacturing capabilities
Deliver a world-class
GMP-compliant maintenance programme
Develop vision and operational discipline across Process Engineering
and Maintenance functions
Provide supervisory direction for department leaders
Ensure regulatory compliance from an equipment
and process performance perspective
Provide technical leadership for troubleshooting
and lifecycle management of manufacturing processes
Drive initiatives that improve process efficiency
Coordinate engineering support for manufacturing operations and daily activities
Implement and manage automated systems and technologies
Ensure compliance with Computer Systems Validation (CSV)
Infrastructure Platform Qualification
and Software Quality practices
Ensure compliance with FDA regulations including 21 CFR Part 11 and applicable computer systems regulations
Oversee the lifecycle management of automation platforms
and digital manufacturing tools
Oversee the development
and execution of a comprehensive maintenance programme
Oversee technical maintenance services
Ensure adequate lifecycle management of plant assets and equipment
Coordinate and allocate resources for daily maintenance operations and projects
Develop and manage annual expense and capital budgets
Control expenses and capital
Ensure all operations comply with Good Manufacturing Practices (GMP)
Good Documentation Practices
and applicable regulatory requirements
Ensure compliance with EHS regulatory agencies and Eli Lilly EHS Corporate
Integrate EHS requirements into business planning
Establish and monitor metrics for inspections
and up-to-date training for all employees and contractors
How You'll Work.
Team & Collaboration
Provide supervisory direction for department leaders, employees, and contractors; Coordinate engineering support for manufacturing operations and daily activities; Coordinate and allocate resources for daily maintenance operations and projects; Teamwork
Communication Scope
Communication skills; Technical writing; Negotiation; Presentation capabilities
Process & Methodology
Manage competing priorities, Drive results in a fast-paced, evolving environment, Organisational skills, Planning and scheduling
Full Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. About the Katwijk Site Eli Lilly is investing €2.6 billion in a new state-of-the-art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next-generation manufacturing technologies including dock-to-dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills. Position Overview The Sr Director, Process, Maintenance & Automation Engineering provides strategic and operational leadership for Process Engineering, Automation, and Maintenance functions at the Katwijk site. This role ensures the reliability, compliance, and continuous performance of manufacturing equipment, control systems, and automated technologies. As a member of the Site Leadership Team, the incumbent will champion next-generation manufacturing capabilities — including paperless operations, dock-to-dock automation, and process analytical technology — while delivering a world-class, GMP-compliant maintenance programme from site startup through steady-state operations. **Key Responsibilities** Leadership & People Management * Develop vision and operational discipline across Process Engineering, Automation, and Maintenance functions in accordance with Eli Lilly Manufacturing Standards. * Provide supervisory direction for department leaders, employees, and contractors across
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