{"schemaVersion":"jobsearcher.job.v1","id":"f12d1e983c3cef978fc0102c","url":"https://jobsearcher.com/jobs/f12d1e983c3cef978fc0102c","canonicalUrl":"https://jobsearcher.com/jobs/f12d1e983c3cef978fc0102c","title":"Process Engineer","description":"Responsibilities Monitor daily production processes to ensure consistent product quality, yield, and adherence to cGMP standards\nSupport root cause analysis and CAPA (Corrective and Preventive Action) efforts for process deviations, non-conformances, and equipment downtime\nAssist in authoring and updating batch records, SOPs, work instructions, and process documentation in compliance with regulatory requirements\nSupport process validation activities, including IQ/OQ/PQ protocols and execution, under guidance of senior engineers\nParticipate in continuous improvement initiatives (Lean, Six Sigma, Kaizen) to optimize process efficiency and reduce variability\nCollect, analyze, and trend production and process data to support performance reporting and process capability studies\nCollaborate with Manufacturing, Quality Assurance, Quality Control, Regulatory, and Maintenance teams to troubleshoot process issues in real time\nSupport equipment qualification, changeover activities, and technology transfer for new or modified processes\nEnsure compliance with FDA regulations, cGMP, and internal quality systems throughout all process engineering activities\nMaintain accurate and audit-ready documentation for process changes, deviations, validation activities, and change controls\nSupport internal and external audits/inspections by providing requested process documentation, data, and technical explanations\nParticipate in safety reviews and ensure adherence to EHS standards specific to pharmaceutical manufacturing (e.g., handling of APIs, cleanroom protocols)\nQualifications Required:\nBachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Pharmaceutical, or related field)\n0–2 years of relevant experience (internships, co-ops, or entry-level engineering roles in pharma/biotech/med device count)\nBasic understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes\nFamiliarity with process validation concepts (IQ/OQ/PQ) and documentation practices\nProficiency with MS Office (Excel, Word, PowerPoint); familiarity with statistical analysis tools a plus\nStrong written and verbal communication skills, with the ability to author clear technical documentation\nAbility to work effectively in a cross-functional, highly regulated team environment\nWillingness to work on the production floor, including gowning/cleanroom protocols as required\n\n#J-18808-Ljbffr","company":"Harba Solutions","rawCompany":"harba solutions","city":"Brooklyn","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-09-02T03:53:22.070Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"}],"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":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Responsibilities Monitor daily production processes to ensure consistent product quality, yield, and adherence to cGMP standards\nSupport root cause analysis and CAPA (Corrective and Preventive Action) efforts for process deviations, non-conformances, and equipment downtime\nAssist in authoring and updating batch records, SOPs, work instructions, and process documentation in compliance with regulatory requirements\nSupport process validation activities, including IQ/OQ/PQ protocols and execution, under guidance of senior engineers\nParticipate in continuous improvement initiatives (Lean, Six Sigma, Kaizen) to optimize process efficiency and reduce variability\nCollect, analyze, and trend production and process data to support performance reporting and process capability studies\nCollaborate with Manufacturing, Quality Assurance, Quality Control, Regulatory, and Maintenance teams to troubleshoot process issues in real time\nSupport equipment qualification, changeover activities, and technology transfer for new or modified processes\nEnsure compliance with FDA regulations, cGMP, and internal quality systems throughout all process engineering activities\nMaintain accurate and audit-ready documentation for process changes, deviations, validation activities, and change controls\nSupport internal and external audits/inspections by providing requested process documentation, data, and technical explanations\nParticipate in safety reviews and ensure adherence to EHS standards specific to pharmaceutical manufacturing (e.g., handling of APIs, cleanroom protocols)\nQualifications Required:\nBachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Pharmaceutical, or related field)\n0–2 years of relevant experience (internships, co-ops, or entry-level engineering roles in pharma/biotech/med device count)\nBasic understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes\nFamiliarity with process validation concepts (IQ/OQ/PQ) and documentation practices\nProficiency with MS Office (Excel, Word, PowerPoint); familiarity with statistical analysis tools a plus\nStrong written and verbal communication skills, with the ability to author clear technical documentation\nAbility to work effectively in a cross-functional, highly regulated team environment\nWillingness to work on the production floor, including gowning/cleanroom protocols as required\n\n#J-18808-Ljbffr","datePosted":"2026-09-02T03:53:22.070Z","dateModified":"2026-09-02T03:53:22.070Z","hiringOrganization":{"@type":"Organization","name":"Harba Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f12d1e983c3cef978fc0102c"},"url":"https://jobsearcher.com/jobs/f12d1e983c3cef978fc0102c"}}