Process Development Engineer (Packaging)
About The Position
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. This position requires on-site presence in Ohio, USA, to support engineering execution, testing, and validation activities. The role involves developing and executing packaging engineering protocols, characterization studies, test methods, and validation activities. The engineer prepares and maintains technical documentation, supports DOE, SPC, and process optimization studies, performs engineering testing and data analysis, and executes IQ, OQ, and PQ activities. The position also supports packaging process development and validation through PPQ approval, participates in risk assessments and technical investigations, and assists with troubleshooting and corrective actions. Engineering deliverables must comply with applicable quality standards, regulatory requirements, and project timelines. The engineer provides progress updates and escalates technical issues to the Principal Engineer.
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.
- 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.
Nice To Haves
- Experience with drug-device combination products, including assembly and packaging processes, is strongly preferred.
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 engineering specifications, test protocols, reports, and process development documentation.
- Support development and execution of Design of Experiments (DOE), Statistical Process Control (SPC), and process optimization studies for packaging processes.
- Perform packaging engineering testing, collect and analyze data, and document 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
