Packaging Process Development Engineer (Pharma)

Inteldot; New Albany (OH); On-site; USD 85,000 - 115,000; 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. 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.

Qualifications

• 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.

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 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.

Skills

Packaging processes experience

DOE

SPC

FMEA

Risk assessments

Statistical data analysis

Engineering test protocols

Technical reporting

Education

Bachelor's degree in Mechanical Engineering or related field

Job description

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.