Job Summary
We are seeking a motivated Principal Engineer to support and optimize our polymer powder production lines. The ideal candidate must have a process engineering background with hands‑on experience in pharmaceutical or synthetic polymer manufacturing and proven experience in tech transfer or developing powder processing unit operations such as fluid bed, coating systems, milling and sieving, and freeze‑drying processes. This role combines process optimization, scale‑up, quality and safety compliance, and cross‑functional troubleshooting.
This individual will provide technical support and leadership to advance innovations for NPIs and LCMs, enhancing yield, reliability, compliance & efficiency of product value chains end‑to‑end, support processes and cycles to be leaner, introduce new capabilities, and collaborate across JNJ functional areas.
Technology Development – Partner with R&D and GTO resources to perform technological scouting, develop, execute, and coordinate studies in laboratory, pilot, or commercial scale environments.
Technical & Scientific Leadership – Provide technical and scientific expertise to enable process control, process understanding, scale‑up/down predictions, and streamline process development.
Strategic Leadership – Support creation, maintenance, and advancement of project strategy; lead key roadmap elements; identify high‑impact areas for new technologies focusing on broad applicability, cost‑saving, and ease of introduction.
Knowledge Management – Develop, manage, troubleshoot, and transfer advanced knowledge on manufacturing technology development.
Investigations – Support independent complex technical investigations, communicate results in presentations, reports, or publications.
People Leadership – May onboard, train, and lead a team of engineers and contractors for study execution.
Key Responsibilities
Lead day‑to‑day technical support for powder processing production equipment.
Knowledge and execution of overall validation lifecycle.
Execute characterization and validation activities, including design of experiments (DoE) to improve yield, throughput, and powder quality while maintaining regulatory and safety compliance.
Scale up laboratory processes from pilot to commercial production, ensuring reproducibility and robustness.
Implement and maintain process controls, statistical process control (SPC), and key performance indicators (KPIs) for production lines.
Lead root‑cause investigations and corrective actions for process deviations and nonconformances.
Work closely with Quality, Regulatory Affairs, Maintenance, and Production to deliver validated, GMP‑compliant processes where applicable.
Develop and maintain process documentation: SOPs, batch records, validation protocols, risk assessments (e.g., HAZOP, FMEA).
Ensure proper handling, storage, and disposal practices for flammable solvents (e.g., acetone) and other hazardous materials; specify ATEX/explosion‑proof equipment where required.
Support continuous improvement initiatives (lean manufacturing, 5S, Kaizen) to reduce cycle time and cost.
Train production staff on process requirements, safety protocols, and quality expectations.
Required Qualifications
Bachelor’s degree (or higher) in Chemical, Mechanical, Biomedical Engineering, Materials Science, or related discipline.
Minimum 8–10 years of experience in pharmaceutical or synthetic polymer manufacturing/process engineering.
Hands‑on experience with pharmaceutical or synthetic polymer manufacturing unit operations.
Strong understanding of solvent handling, flammability controls, ventilation, and explosion‑proof equipment requirements.
Experience with process scale‑up, DoE, SPC, and root‑cause analysis tools (e.g., DMAIC, 8D).
Familiarity with GMP and regulatory documentation practices if working in a pharmaceutical environment.
Strong problem‑solving, data analysis, and technical communication skills.
Preferred Qualifications
Advanced degree (MSc/PhD) in Chemistry, Chemical/Mechanical/Biomedical Engineering, or Materials Science.
Experience with solvent recovery systems and environmental/waste treatment for organic solvents.
Experience with powder characterization techniques (PSD, BET, SEM).
Prior experience leading cross‑functional projects and driving continuous improvement programs.
Working Conditions & Safety
Work is primarily plant‑based with regular collaboration across R&D, QA, and Production.
Role requires adherence to strict safety protocols for handling solvents like acetone (flammability, static control, ignition source management).
May require occasional support for off‑shift troubleshooting or scale‑up campaigns.
What We Offer
Opportunity to lead process improvements on commercial polymer powder lines.
Collaborative environment with emphasis on safety, quality, and continuous improvement.
Professional development and potential leadership growth.
Compensation
The anticipated base pay range for this position is 68,600 EUR to 119,600 EUR annually, plus 8% holiday allowance.
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