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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.
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