Sr Principal Associate – Process Engineering - OSD

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.

Role Overview

We are hiring for two Sr. Principal Engineer (Process Engineering) positions at a brand-new pharmaceutical manufacturing site being built in the Netherlands. Both roles carry the same responsibilities and team structure, the distinction is process specialism:

Variant 1, Oral Solid Dosage (OSD): direct compression, coating. SDD experience a plus.

Variant 2, Spray-Dried Dispersion (SDD): spray drying, amorphous solid dispersion, polymer/solvent systems, solvent handling at scale. Broader OSD experience a strong plus.

Please indicate your primary process focus when applying.

What You'll Be Doing

Process Design

Define manufacturing processes at scale, providing technical input into equipment selection, process flows, and plant layout

Translate high-level design concepts into practical solutions during the detailed design phase

Ensure process designs align with safety requirements, scalability, efficiency, and long-term operability

Identify and resolve process design gaps before they become operational problems

Technical Expertise

Act as subject matter expert for your process area (OSD or SDD)

Guide technical decisions on process feasibility, material handling, solvent controls, and equipment specification

Author and review technical documents including URS, design documents, change controls, and deviation investigations

Apply structured problem-solving tools including FMEA, HAZOP, SPC, DoE, and RCA

Commissioning & Qualification

Support process validation and C&Q strategy for your process area, including IQ, OQ, and PQ execution

Define and manage the AQM/AQbD strategy for the process

Support FAT and SAT activities with equipment vendors

Provide on-call technical support during commissioning and early operations

Cross-functional Collaboration

Partner with Quality, EHS, Manufacturing Operations, and MSAT to align process design with compliance requirements

Interface with the Engineering Technical Centre, external vendors, and project stakeholders

Work closely with automation and maintenance teams throughout design and build phases

Coaching & Development

Mentor junior process engineers as the site team grows

Contribute to technical screening and interview panels

Champion engineering best practice and technical standards across the site

Basic Requirements

Bachelor's degree in Chemical or Mechanical Engineering, or equivalent

6–8+ years in pharmaceutical process engineering at senior individual contributor level

Hands-on experience in the relevant process area (OSD or SDD, see variants above)

Solvent-handling experience essential for SDD variant

Working knowledge of EU GMP (EudraLex Volume 4), ICH Q7–Q10, GDP, and pharmaceutical quality systems

Practical experience with FMEA, SPC, HAZOP, RCA, and GMP documentation (change controls, deviation investigations, protocols)

Professional fluency in English

Based on-site full-time in the Netherlands; 24/7 availability during commissioning

Additional Preferred Skills

Master's degree in Chemical, Pharmaceutical, or Process Engineering

Prior experience on a greenfield site, plant start-up, or major capital project

ATEX/DSEAR knowledge (particularly relevant for SDD solvent-handling operations)

Exposure to PAT, MES, and automated/paperless manufacturing environments

Lean/Six Sigma Green Belt or Black Belt

Dutch language (conversational or above)

Track record of mentoring and developing junior engineers

Additional Information

Relocation support is available for candidates based outside the Netherlands. Occasional travel required for vendor visits, sister-site collaboration, and project meetings.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. 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.

#WeAreLilly

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.

#WeAreLilly