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Open nowPosted 7 days ago

Process Development Engineer (Packaging)

Inteldot23 open roles

Where
New Albany, Ohio, United States
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Your applicationOpen nowProcess Development Engineer (Packaging)Inteldot · New Albany, Ohio, United States

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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Inteldot postings stay open a median of 17 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted 7 days ago

Inteldot median: 17 days open

The posting

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.

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