{"schemaVersion":"jobsearcher.job.v1","id":"a066cc0a210faaaf0bb0bc2b","url":"https://jobsearcher.com/jobs/a066cc0a210faaaf0bb0bc2b","canonicalUrl":"https://jobsearcher.com/jobs/a066cc0a210faaaf0bb0bc2b","title":"Process Engineer II","description":"We are looking for a Process Engineer who has the technical expertise in the Engineering processes to ensure support, availability, and maintenance of those system(s) throughout the lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.\n\nDuties & Responsibilities\n\nYou must have a willingness to perform \"hands‑on\" work in a dynamic, team‑oriented work setting.\n\nProvide technical expertise on CQV activities and ensures compliance to regulatory requirements, industry best practices, and Engineering standards.\n\nParticipate directly in the Engineering process to develop and institute technical and procedural controls in the process design.\n\nAccountable for CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.\n\nExecute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.\n\nAnticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.\n\nLead and participate in cross‑functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.\n\nInterpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.\n\nRequired Qualifications\n\nBachelors degree in Engineering required.\n\nStrong mechanical aptitude.\n\nDemonstrated ability to solve technical problems and implement projects.\n\nExcellent interpersonal and communication skills, and fluency in English.\n\nSelf‑directed with effective analytical and problem‑solving skills.\n\nMust be able to deliver results on multiple complex assignments simultaneously in a fast‑paced environment.\n\nInteract well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.\n\nWillingness to adapt to changing priorities as project demands change.\n\nPreferred Qualifications\n\n5+ years of experience in sterile injectables, drug‑device combination products, or biologics.\n\nSME‑level knowledge of drug product processing equipment (e.g. single‑use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment vials, pre‑filled syringes, and cartridges isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).\n\nDirect experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.\n\nFamiliarity with cleaning validation and/or process validation.\n\nPrevious work at greenfield sites or substantial facility expansion projects.\n\n#J-18808-Ljbffr","company":"BioSpace","rawCompany":"biospace","city":"Charlottesville","state":"VA","isRemote":false,"isActive":false,"createdAt":"2026-06-20T03:45:46.194Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer II","description":"We are looking for a Process Engineer who has the technical expertise in the Engineering processes to ensure support, availability, and maintenance of those system(s) throughout the lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.\n\nDuties & Responsibilities\n\nYou must have a willingness to perform \"hands‑on\" work in a dynamic, team‑oriented work setting.\n\nProvide technical expertise on CQV activities and ensures compliance to regulatory requirements, industry best practices, and Engineering standards.\n\nParticipate directly in the Engineering process to develop and institute technical and procedural controls in the process design.\n\nAccountable for CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.\n\nExecute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.\n\nAnticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.\n\nLead and participate in cross‑functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.\n\nInterpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.\n\nRequired Qualifications\n\nBachelors degree in Engineering required.\n\nStrong mechanical aptitude.\n\nDemonstrated ability to solve technical problems and implement projects.\n\nExcellent interpersonal and communication skills, and fluency in English.\n\nSelf‑directed with effective analytical and problem‑solving skills.\n\nMust be able to deliver results on multiple complex assignments simultaneously in a fast‑paced environment.\n\nInteract well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.\n\nWillingness to adapt to changing priorities as project demands change.\n\nPreferred Qualifications\n\n5+ years of experience in sterile injectables, drug‑device combination products, or biologics.\n\nSME‑level knowledge of drug product processing equipment (e.g. single‑use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment vials, pre‑filled syringes, and cartridges isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).\n\nDirect experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.\n\nFamiliarity with cleaning validation and/or process validation.\n\nPrevious work at greenfield sites or substantial facility expansion projects.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T03:45:46.194Z","dateModified":"2026-06-20T03:45:46.194Z","hiringOrganization":{"@type":"Organization","name":"BioSpace","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Charlottesville","addressRegion":"VA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a066cc0a210faaaf0bb0bc2b"},"url":"https://jobsearcher.com/jobs/a066cc0a210faaaf0bb0bc2b"}}