Sr Principal Associate – Process Engineering - OSD/SDD

Biopharma Careers; Katwijk; On-site; EUR 68,000 - 121,000; Full time

Benefits offered by this job

Relocation support

Company bonus program

Pension plan

Healthcare benefits

Job summary

Lilly is hiring two Sr. Principal Engineer (Process Engineering) roles for a brand-new Netherlands site. You will define scalable manufacturing processes (OSD or SDD), guide design, and support commissioning, qualification, and cross-functional compliance.

Role requires 6–8+ years in pharma process engineering, solvent handling for SDD, and strong English; relocation support is available for the Netherlands site (onsite).

Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering and 6–8+ years in pharma process engineering.
• Hands-on experience in the relevant process area (OSD or SDD) and solvent handling for SDD.
• Working knowledge of EU GMP, ICH Q7–Q10, GDP, and GMP documentation.

Responsibilities

• Define manufacturing processes at scale and advise equipment selection and plant layout.
• Provide solutions during detailed design and ensure safety, scalability, and operability.
• Support process validation, IQ/OQ/PQ, and commissioning activities.
• Collaborate with Quality, EHS, Manufacturing Operations, and MSAT teams.

Skills

Chemical/Mechanical Eng

Process engineering experience

Solvent handling

GMP knowledge

FMEA

SPC

HAZOP

RCA

English fluency

Education

Bachelor's degree in Chemical or Mechanical Engineering

Master's degree (preferred)

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.

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 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is €67,500 - €121,000

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.

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.