Sr Principal Associate – Process Engineering - OSD​/SDD

Location: Katwijk NB

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.
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)

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 ader 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 (Eudra Lex 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…