PD Engineer (Packaging)

Inteldot; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Inteldot is seeking experienced Process Development Engineers to support development, characterization, verification, and validation of packaging processes for pharmaceutical and drug-device products.

The role focuses on executing packaging engineering activities, developing protocols, and ensuring regulatory compliance, with on-site work in Ohio, USA. Candidates should have a Bachelor's degree in engineering and at least 2 years in packaging processes.

Qualifications

• Bachelor's degree in the specified engineering fields.
• At least 2 years of packaging process engineering experience.
• Experience with drug-device packaging assembly and packaging processes preferred.
• Familiar with IQ/OQ/PQ validation and DOE/SPC/FMEA.

Responsibilities

• Execute packaging engineering activities for development, verification, and validation.
• Develop packaging protocols, tests, and validation activities.
• Prepare technical docs including specs, test plans, and reports.
• Support DOE, SPC, and process optimization studies.
• Conduct testing, data analysis, and document results.
• Assist with IQ/OQ/PQ activities and PPQ approvals.
• Ensure compliance with quality standards and regulatory timelines.
• Provide progress updates and escalate issues to the Principal Engineer.

Skills

Packaging processes

DOE

SPC

FMEA

IQ/OQ/PQ

Technical reports

Root cause analysis

Regulatory docs

Drawings interpretation

Drug-device packaging

Education

Bachelor's degree in engineering

Job description

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 escalates 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.