{"schemaVersion":"jobsearcher.job.v1","id":"7c0a8d27e7dfaa4ae5255ee8","url":"https://jobsearcher.com/jobs/7c0a8d27e7dfaa4ae5255ee8","canonicalUrl":"https://jobsearcher.com/jobs/7c0a8d27e7dfaa4ae5255ee8","title":"Validation Specialist Aseptic Process Simulation (APS) Temp","description":"Job Description\nValidation Specialist – Aseptic Process Simulation (APS)\nSterile Injectable Manufacturing | Whippany, New Jersey\nPosition Summary\nHalo Pharmaceutical, a leading North American CDMO is expanding its sterile injectable manufacturing capabilities at its Whippany, NJ facility with a new syringe, cartridge, and vial filling line. As part of this expansion, we are seeking a highly skilled Validation Specialist – Aseptic Process Simulation (APS) to own, execute, and continuously manage our 20-hour time-based media fill program in accordance with FDA, EU GMP Annex 1, and USP requirements.\nThis role is critical to demonstrating ongoing aseptic process capability and to supporting the commercial launch of sterile injectable products. The successful candidate will bring deep technical knowledge of media fill program design, microbiological principles, isolator and RABS operations, and current regulatory expectations, and will thrive in a hands-on, in-house qualification environment.\nKey Responsibilities\nAseptic Process Simulation Program Ownership\nDesign, author, and maintain the site APS program based on a media fill model, encompassing worst-case process simulation parameters consistent with commercial filling operations.\nAuthor and revise APS protocols, batch records, and summary reports for initial qualification runs and routine periodic media fills.\nEstablish and maintain APS bracketing and worst-case rationale documentation (e.g., shift duration, personnel interventions, line speed, container-closure configurations) in compliance with FDA and EU GMP Annex 1 requirements.\nManage the media fill schedule, ensuring fills are conducted at defined intervals per regulatory requirements and internal SOPs.\nExecution and Operations\nLead hands-on execution of media fills on the Groninger UFVN FlexFill filling line and SKAN isolator, including gowning, line setup, aseptic manipulations, and interventions representative of commercial operations.\nCoordinate all personnel involved in APS activities, including training on roles, responsibilities, and correct aseptic technique during simulation runs.\nOversee incubation, inspection, and disposition of filled media units; investigate and document any positive units in accordance with site investigation procedures.\nEnsure all APS activities are executed in accordance with approved protocols and cGMP requirements; escalate deviations or unexpected results in a timely manner.\nEquipment Qualification and Utility Interface\nInterface with IQ/OQ/PQ activities for the sterile filling line, SKAN isolator, environmental monitoring systems, and associated critical utilities (compressed air, nitrogen, WFI, clean steam) as they relate to APS readiness.\nSupport environmental monitoring (EM) program execution during media fills, including viable and non-viable particulate monitoring in ISO 5 / Grade A and ISO 7 / Grade B classified environments.\nCollaborate on HVAC qualification and room classification studies to ensure the aseptic processing suite meets regulatory expectations prior to and during APS execution.\nDocumentation and Regulatory Compliance\nAuthor, review, and maintain APS-related SOPs, risk assessments, and Validation Master Plan (VMP) sections covering aseptic process simulation.\nPrepare APS summary reports suitable for regulatory submissions (NDA/ANDA CMC sections, pre-approval inspections, and BLA filings).\nMaintain APS program documentation in an inspection-ready state at all times; serve as the subject-matter expert (SME) for FDA, Health Canada, EMA, and client audits.\nEnsure all APS activities are traceable to applicable equipment qualification activities (IQ/OQ/PQ) and facility qualification records. Track and trend APS results over time; identify adverse trends and initiate CAPAs as appropriate.\nCross-Functional Collaboration\nPartner with Manufacturing, Quality Assurance, Microbiology, and Regulatory Affairs teams to integrate APS requirements into new product introductions and technology transfers.\nRequired Qualifications\nEducation\nBachelor of Science in Microbiology, Biology, Pharmacy, Chemical Engineering, or a related life science discipline\nExperience\nMinimum 3-5 years of pharmaceutical validation experience with direct hands-on experience in aseptic process simulation and media fills in a cGMP sterile manufacturing environment\nRegulatory Knowledge\nWorking knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 1 (2022 revision), USP 1116, PDA Technical Report No. 22, and ISO 14644 cleanroom standards\nTechnical Skills\nExperience with isolator technology (SKAN or equivalent), automated filling equipment, and environmental monitoring systems; familiarity with vial, syringe, and cartridge fill-finish operations preferred.\nPreferred Qualifications\nExperience with 20-hour or extended-duration time-based media fill programs.\nFamiliarity with Groninger FlexFill or similar high-speed fill-finish platforms.\nBackground in CDMO environments with multi-product aseptic manufacturing portfolios.\nExperience supporting FDA pre-approval inspections (PAIs) or Health Canada GMP inspections as the APS subject-matter expert.\nKnowledge of risk-based Contamination Control Strategies (CCS) as required by EU GMP Annex 1 (2022).\nASQ Certified Quality Engineer (CQE), PDA training, or equivalent professional certification preferred.\nCore Competencies\nTechnical Precision\nDeep understanding of aseptic processing science, microbiological risk, and contamination control in sterile drug manufacturing\nRegulatory Acumen\nAbility to translate current regulatory guidance into site-specific APS program design and compliant documentation\nAttention to Detail\nMeticulous in protocol execution, GMP documentation, and data integrity compliance\nProblem Solving\nSkilled in root cause investigation for APS failures or positive unit events, including CAPA development and effectiveness monitoring\nCollaboration\nWorks effectively across Manufacturing, QA, Microbiology, Regulatory Affairs, and client teams in a fast-paced CDMO environment\nCommunication\nClear and concise technical writing and verbal communication skills, including the ability to present validation data to regulatory agencies and clients\nJob Type: Temporary\nPay: $45.00 per hour\nWork Location: In person","company":"Interactengineeringll","rawCompany":"interactengineeringll","city":"Morris Twp","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-08-03T17:12:45.690Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Specialist Aseptic Process Simulation (APS) Temp","description":"Job Description\nValidation Specialist – Aseptic Process Simulation (APS)\nSterile Injectable Manufacturing | Whippany, New Jersey\nPosition Summary\nHalo Pharmaceutical, a leading North American CDMO is expanding its sterile injectable manufacturing capabilities at its Whippany, NJ facility with a new syringe, cartridge, and vial filling line. As part of this expansion, we are seeking a highly skilled Validation Specialist – Aseptic Process Simulation (APS) to own, execute, and continuously manage our 20-hour time-based media fill program in accordance with FDA, EU GMP Annex 1, and USP requirements.\nThis role is critical to demonstrating ongoing aseptic process capability and to supporting the commercial launch of sterile injectable products. The successful candidate will bring deep technical knowledge of media fill program design, microbiological principles, isolator and RABS operations, and current regulatory expectations, and will thrive in a hands-on, in-house qualification environment.\nKey Responsibilities\nAseptic Process Simulation Program Ownership\nDesign, author, and maintain the site APS program based on a media fill model, encompassing worst-case process simulation parameters consistent with commercial filling operations.\nAuthor and revise APS protocols, batch records, and summary reports for initial qualification runs and routine periodic media fills.\nEstablish and maintain APS bracketing and worst-case rationale documentation (e.g., shift duration, personnel interventions, line speed, container-closure configurations) in compliance with FDA and EU GMP Annex 1 requirements.\nManage the media fill schedule, ensuring fills are conducted at defined intervals per regulatory requirements and internal SOPs.\nExecution and Operations\nLead hands-on execution of media fills on the Groninger UFVN FlexFill filling line and SKAN isolator, including gowning, line setup, aseptic manipulations, and interventions representative of commercial operations.\nCoordinate all personnel involved in APS activities, including training on roles, responsibilities, and correct aseptic technique during simulation runs.\nOversee incubation, inspection, and disposition of filled media units; investigate and document any positive units in accordance with site investigation procedures.\nEnsure all APS activities are executed in accordance with approved protocols and cGMP requirements; escalate deviations or unexpected results in a timely manner.\nEquipment Qualification and Utility Interface\nInterface with IQ/OQ/PQ activities for the sterile filling line, SKAN isolator, environmental monitoring systems, and associated critical utilities (compressed air, nitrogen, WFI, clean steam) as they relate to APS readiness.\nSupport environmental monitoring (EM) program execution during media fills, including viable and non-viable particulate monitoring in ISO 5 / Grade A and ISO 7 / Grade B classified environments.\nCollaborate on HVAC qualification and room classification studies to ensure the aseptic processing suite meets regulatory expectations prior to and during APS execution.\nDocumentation and Regulatory Compliance\nAuthor, review, and maintain APS-related SOPs, risk assessments, and Validation Master Plan (VMP) sections covering aseptic process simulation.\nPrepare APS summary reports suitable for regulatory submissions (NDA/ANDA CMC sections, pre-approval inspections, and BLA filings).\nMaintain APS program documentation in an inspection-ready state at all times; serve as the subject-matter expert (SME) for FDA, Health Canada, EMA, and client audits.\nEnsure all APS activities are traceable to applicable equipment qualification activities (IQ/OQ/PQ) and facility qualification records. Track and trend APS results over time; identify adverse trends and initiate CAPAs as appropriate.\nCross-Functional Collaboration\nPartner with Manufacturing, Quality Assurance, Microbiology, and Regulatory Affairs teams to integrate APS requirements into new product introductions and technology transfers.\nRequired Qualifications\nEducation\nBachelor of Science in Microbiology, Biology, Pharmacy, Chemical Engineering, or a related life science discipline\nExperience\nMinimum 3-5 years of pharmaceutical validation experience with direct hands-on experience in aseptic process simulation and media fills in a cGMP sterile manufacturing environment\nRegulatory Knowledge\nWorking knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 1 (2022 revision), USP 1116, PDA Technical Report No. 22, and ISO 14644 cleanroom standards\nTechnical Skills\nExperience with isolator technology (SKAN or equivalent), automated filling equipment, and environmental monitoring systems; familiarity with vial, syringe, and cartridge fill-finish operations preferred.\nPreferred Qualifications\nExperience with 20-hour or extended-duration time-based media fill programs.\nFamiliarity with Groninger FlexFill or similar high-speed fill-finish platforms.\nBackground in CDMO environments with multi-product aseptic manufacturing portfolios.\nExperience supporting FDA pre-approval inspections (PAIs) or Health Canada GMP inspections as the APS subject-matter expert.\nKnowledge of risk-based Contamination Control Strategies (CCS) as required by EU GMP Annex 1 (2022).\nASQ Certified Quality Engineer (CQE), PDA training, or equivalent professional certification preferred.\nCore Competencies\nTechnical Precision\nDeep understanding of aseptic processing science, microbiological risk, and contamination control in sterile drug manufacturing\nRegulatory Acumen\nAbility to translate current regulatory guidance into site-specific APS program design and compliant documentation\nAttention to Detail\nMeticulous in protocol execution, GMP documentation, and data integrity compliance\nProblem Solving\nSkilled in root cause investigation for APS failures or positive unit events, including CAPA development and effectiveness monitoring\nCollaboration\nWorks effectively across Manufacturing, QA, Microbiology, Regulatory Affairs, and client teams in a fast-paced CDMO environment\nCommunication\nClear and concise technical writing and verbal communication skills, including the ability to present validation data to regulatory agencies and clients\nJob Type: Temporary\nPay: $45.00 per hour\nWork Location: In person","datePosted":"2026-08-03T17:12:45.690Z","dateModified":"2026-08-03T17:12:45.690Z","hiringOrganization":{"@type":"Organization","name":"Interactengineeringll","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Morris Twp","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7c0a8d27e7dfaa4ae5255ee8"},"url":"https://jobsearcher.com/jobs/7c0a8d27e7dfaa4ae5255ee8"}}