{"id":3526703,"url":"https://alion.io/job/inteldot-process-development-engineer-packaging","title":"Process Development Engineer (Packaging)","company":{"id":4418608,"name":"Inteldot","domain":"inteldot.com","url":"https://alion.io/company/inteldot","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Breezy","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["New Albany, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":150000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":132},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Design of Experiments","optional":false},{"name":"FMEA","optional":false},{"name":"Statistical Process Control","optional":false}],"status":"live","first_seen_at":"2026-10-30T14:18:38Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-01T12:37:57Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Position Summary\nInteldot is seeking experienced Process Development Engineers to support the development, characterization, verification, and validation of packaging processes for pharmaceutical and drug-device combination products.\nKey Responsibilities\nExecute packaging engineering activities related to process development, characterization, verification, and validation of drug-device combination products.\nDevelop and execute packaging engineering protocols, characterization studies, test methods, and validation activities.\nPrepare and maintain technical documentation, including engineering specifications, test protocols, reports, and process development documentation.\nSupport the development and execution of Design of Experiments (DOE), Statistical Process Control (SPC), and process optimization studies for packaging processes.\nPerform packaging engineering testing, data collection, analysis, and documentation of results.\nExecute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.\nSupport packaging process development and validation activities through PPQ approval.\nParticipate in risk assessments, Failure Mode and Effects Analysis (FMEA), and technical investigations.\nAssist with troubleshooting, root cause analysis, and implementation of corrective actions.\nSupport engineering activities associated with drug-device combination product assembly and packaging processes.\nEnsure engineering deliverables comply with applicable quality standards, regulatory requirements, and project timelines.\nProvide regular progress updates and escalate technical issues to the Principal Engineer.\nSkills & Requirements\nBachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline.\nAt least 2 years of engineering experience in packaging processes for the pharmaceutical, biotechnology, or medical device industry.\nExperience supporting packaging process development, characterization, verification, and validation activities.\nExperience with drug-device combination products, including assembly and packaging processes, strongly preferred.\nHands-on experience developing and executing engineering test protocols and preparing technical reports.\nKnowledge of process validation methodologies, including IQ, OQ, PQ, and PPQ.\nFamiliarity with DOE, SPC, FMEA, risk assessments, and statistical data analysis.\nExperience developing or supporting material specifications, test specifications, and engineering documentation.\nAbility to interpret technical drawings, engineering specifications, procedures, and regulatory documentation.\nWork Location\nThis position requires on-site presence in Ohio, USA, to support engineering execution, testing, and validation 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