Associate Director - Process Engineering (m/w/d)

436 Eli Lilly Nederland B.V.; Katwijk; On-site; EUR 140,000 - 190,000; Full time

Job summary

Eli Lilly Nederland B.V. in Katwijk seeks an Associate Director-Process Engineering to lead the Process Engineering group and sustain systems ensuring reliable operations and qualified process equipment on site.

The role starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit. The position requires BS in Engineering and 6+ years in pharma engineering, with 3+ years in Drug Product Solid Operations, OSd experience preferred, and strong GMP

Qualifications

• BS in Engineering (Mechanical, Chemical or related).
• At least 6 years in pharmaceutical industry engineering.
• At least 3 years in Drug Product Solid Operations (facilities/equipment design, construction, startup and/or spray drying).
• Strong experience in Oral Solid Dose (OSD) manufacturing preferred.
• GMP-regulated pharmaceutical manufacturing experience required.

Responsibilities

• Provide oversight of process equipment across all manufacturing steps.
• Establish control systems to monitor and verify equipment performance.
• Lead qualification and validation activities with internal and external resources.
• Lead and support troubleshooting using Root Cause Analysis, FMEA and cross-functional teams.
• Lead complex technical discussions across sites and drive continuous improvement.

Skills

Leadership

Project management

GMP knowledge

Education

BS in Engineering

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 Associate Director-Process Engineering is responsible for leading the Process Engineering group establishing and sustaining systems to ensure reliable operations and the qualified state of process equipment on site. Ensures that process equipment is in control, compliant and capable of meeting plant production requirements while also driving continuous improvement efforts. Additionally, will lead the process engineering organization and influence other functional disciplines to support the process engineering technical agenda, and site business plan objectives. This position starts with a 12-month contract, with the intention of offering a permanent contract based on mutual fit. (Dienstverband: tijdelijk met uitzicht op vast)

Key Responsibilities

Process Equipment & Technical Oversight

• Provide oversight of process equipment across all manufacturing steps, ensuring clear understanding of equipment flow, process flow, and critical process requirements
• Establish control systems to monitor, trend, and verify process equipment performance
• Ensure asset qualification review is performed across all process steps according to defined strategy
• Lead and support troubleshooting efforts using formal problem-solving techniques (Root Cause Analysis, FMEA), in alignment with TS/MS, QA, Maintenance, and Automation teams
• Ensure engineering standards are applied consistently across all process teams

Process Improvement & Innovation

• Identify and lead improvement opportunities associated with equipment and processes across site
• Evaluate new equipment technologies, raw materials, and facilities; create strategies for new validation and technical approaches
• Proactively propose and implement practices to prevent recurrence of complex issues
• Generate, evaluate, execute, and approve change controls
• Coordinate new technology introductions, trials, and startups
• Stay current with industry technical standards and share best practices across the network

Qualification & Validation

• Lead design and implementation of new or modified equipment, utilities, and facilities to ensure compliance with qualification requirements and applicable regulations
• Manage qualification and validation activities in collaboration with internal and external resources, including all associated documentation

Project & Financial Management

• Ensure projects are delivered on schedule
• Maintain financial oversight of Process Engineering group
• Manage budget for assigned projects and business plan activities
• Develop, maintain, and approve professional services accounts and contracts

EHS Support

• Support the site EHS agenda including Dust Explosion, Industrial Ergonomics, and Containment programmes
• Participate in Self Audits and other EHS-related activities as required

Cross-Functional & Site Leadership

• Participate as a core member of the Site leadership team
• Collaborate with the Engineering Tech Center to share lessons learned and drive continuous improvement
• Lead complex technical discussions across sites
• Respond to and deliver on customer requests related to process equipment

People Leadership & Development

• Build and develop a high-performing Process Engineering organisation aligned with Lilly Values
• Lead the performance management process, including development plans and career path support
• Ensure people in responsible positions are qualified and training compliance is maintained
• Hold team accountable to goals and objectives
• Manage resources effectively to deliver site and team commitments
• Understand and ensure periodic assessment of the function’s compliance with MSOE standards

Educational Requirements

BS in Engineering (Mechanical, Chemical or related).

Experience Requirements

• At least 6 (six) years in pharmaceutical industry engineering or equivalent relevant experience.
• At least 3 (three) years experience in Drug Product Solid Operations including experience in facilities/equipment design, construction and start up and/or spray drying dispersion.
• Strong experience within Oral Solid Dose (OSD) pharmaceutical manufacturing is preferred.
• Candidates with relevant Spray Drying experience and strong learning agility may also be considered.
• Experience supporting the design, qualification, start-up and validation of pharmaceutical manufacturing equipment and processes, ideally within Oral Solid Dose (OSD) and/or Spray Drying environment is preferred.
• Previous experience leading and managing Process Engineers within a pharmaceutical manufacturing environment is required.
• Demonstrated experience supporting the start-up and implementation of manufacturing projects and equipment.
• Greenfield site experience is not required.
• Strong experience working within a GMP-regulated pharmaceutical manufacturing environment is required.
• Technical experience supporting process and technology transfers and/or the introduction of new processes and technologies within pharmaceutical operations.
• Experience managing projects across multiple functional areas, including cross-functional integration and coordination

Other Requirements

• Professional fluency in English, Dutch is preferred
• Able to work during extended periods, work under pressure, and good judgment under special circumstances.
• Able to travel (within and outside country)
• Self-starter, teamwork oriented.

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $ - $. Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

Equal Opportunity Statement

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!