Process Development Engineer (Packaging)

Inteldot; New Albany (OH); Presencial; USD 85.000 - 115.000; Jornada completa

Descripción de la vacante

Inteldot is seeking experienced Process Development Engineers to support development, characterization, verification, and validation of packaging processes for pharmaceutical and drug-device products. You will develop protocols, perform DOE/SPC studies, and prepare comprehensive technical documentation.

On-site in Ohio, you’ll contribute to risk assessments, FMEA, and continuous improvement while ensuring regulatory compliance.

Formación

• 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.

Responsabilidades

• 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 DOE, SPC, and PPQ studies for packaging processes.
• Perform packaging engineering testing, data collection, analysis, and documentation of results.
• Assist with IQ, OQ, and PQ activities and PPQ approvals.
• Support engineering activities for assembly and packaging processes for drug-device products.
• Ensure deliverables comply with quality standards, regulatory requirements, and project timelines.

Conocimientos

Packaging processes experience

DOE

SPC

FMEA

Risk assessments

Statistical data analysis

Engineering test protocols

Technical reporting

Educación

Bachelor's degree in Mechanical Engineering or related field

Descripción del empleo

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 elevate 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.