Associate Director - Process Engineering

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.