Principal Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

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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 handson 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 freezedrying processes. This role combines process optimization scaleup quality and safety compliance and crossfunctional troubleshooting.

This individual will provide technical support and leadership to support the advancement of innovations for NPIs; LCMs to enhance yield reliability compliance & efficiency of product value chains end-to-end i.e. support to make manufacturing processes/cycles leaner; new capabilities and effectively collaborate across different JNJ functional areas.

Technology Development This individual will partner with R&D and other GTO resources to perform technological scouting develop execute and/or coordinate studies in laboratory pilot or commercial scale environments.

Technical and Scientific Leadership This individual will provide technical and scientific expertise with the final aim of enabling process control process understanding scale-up / down predictions and enhancing / streamlining process development.

Strategic Leadership This individual will support the creation maintenance and advancement of an overall strategy for projects or lead key elements of the strategic roadmap. Identify areas of highest impact for implementation of new technologies focusing on broad applicability cost-saving and ease of introduction.

Knowledge Management This individual will develop manage troubleshoot and transfer advanced knowledge on new or marketed products manufacturing technologies development and deployment.

Investigations - This individual will support and independently develop complex technical investigations to resolve issues. The team member will need to effectively communicate the results and potential application of investigations in presentation reports or publications.

People Leadership - This individual may onboard train and lead a team of engineers contractors to advance study execution.

Key Responsibilities

• Lead daytoday technical support for powder processing production equipments.

• 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 rootcause investigations and corrective actions for process deviations and nonconformances.

• Work closely with Quality Regulatory Affairs Maintenance and Production to deliver validated GMPcompliant 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/explosionproof 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

• Bachelors 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.

• Handson experience with pharmaceutical or synthetic polymer manufacturing unit operations.

• Strong understanding of solvent handling flammability controls ventilation and explosionproof equipment requirements.

• Experience with process scaleup DoE SPC and rootcause analysis tools (e.g. DMAIC 8D).

• Familiarity with GMP and regulatory documentation practices if working in a pharmaceutical environment.

• Strong problemsolving 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 crossfunctional projects and driving continuous improvement programs.

Working Conditions & Safety

• Work is primarily plantbased 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 offshift troubleshooting or scaleup 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.

The anticipated base pay range for this position is 68.600 EUR to 119.600 EUR on an annual basis and includes 8% holiday allowance.

How to Apply

Please send your resume and a brief cover letter highlighting specific tech transfer / powder scale up projects and improvements you led to the hiring contact listed on our careers page.

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