Position Summary
Inteldot is seeking experienced Process Development Engineers to support the development, characterization, verification, and validation of packaging processes for pharmaceutical and drug-device combination products.
Key Responsibilities
- Execute packaging engineering activities related to process development, characterization, verification, and validation of drug-device combination products.
- Develop and execute packaging engineering protocols, characterization studies, test methods, and validation activities.
- Prepare and maintain technical documentation, including engineering specifications, test protocols, reports, and process development documentation.
- Support the development and execution of Design of Experiments (DOE), Statistical Process Control (SPC), and process optimization studies for packaging processes.
- Perform packaging engineering testing, data collection, analysis, and documentation of results.
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Support packaging process development and validation activities through PPQ approval.
- Participate in risk assessments, Failure Mode and Effects Analysis (FMEA), and technical investigations.
- Assist with troubleshooting, root cause analysis, and implementation of corrective actions.
- Support engineering activities associated with drug-device combination product assembly and packaging processes.
- Ensure engineering deliverables comply with applicable quality standards, regulatory requirements, and project timelines.
- Provide regular progress updates and escalate technical issues to the Principal Engineer.
Skills & Requirements
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline.
- At least 2 years of engineering experience in packaging processes for the pharmaceutical, biotechnology, or medical device industry.
- Experience supporting packaging process development, characterization, verification, and validation activities.
- Experience with drug-device combination products, including assembly and packaging processes, strongly preferred.
- Hands-on experience developing and executing engineering test protocols and preparing technical reports.
- Knowledge of process validation methodologies, including IQ, OQ, PQ, and PPQ.
- Familiarity with DOE, SPC, FMEA, risk assessments, and statistical data analysis.
- Experience developing or supporting material specifications, test specifications, and engineering documentation.
- Ability to interpret technical drawings, engineering specifications, procedures, and regulatory documentation.
Work Location
This position requires on-site presence in Ohio, USA, to support engineering execution, testing, and validation activities.