{"schemaVersion":"jobsearcher.job.v1","id":"84f65e39ca4e187b07bdb011","url":"https://jobsearcher.com/jobs/84f65e39ca4e187b07bdb011","canonicalUrl":"https://jobsearcher.com/jobs/84f65e39ca4e187b07bdb011","title":"Automation CSV Engineer","description":"Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.\nADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.\nADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.\nThe successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.\nThis is an outstanding opportunity to join our growing team!\nPosition Overview\nWe are seeking an experienced Sr. Automation CSV Engineer to support a complex automation system migration project at a large, regulated biotechnology/pharmaceutical manufacturing site in the California Bay area. The ideal candidate will bring deep, hands-on expertise in PCS and MES system migration, validation, and implementation, with a strong preference for experience in Rockwell and PharmaSuite environments.\nThis role requires a senior-level engineer capable of independently executing and leading CSV and automation activities while collaborating closely with cross-functional teams.\nKey Responsibilities\n\nLead and execute CSV and automation activities for PCS/MES system migration projects\nSupport implementation, migration, commissioning, and validation of:\nPCS systems (Rockwell, Honeywell)\nMES systems (PharmaSuite, POMSnet)\nSCADA and PLC platforms\nAuthor, review, approve, and execute CSV lifecycle documentation, including:\nValidation Plans\nTest Protocols (IQ/OQ/PQ)\nTraceability Matrices\nValidation Summary Reports\nEnsure compliance with SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5\nManage and document software changes throughout the SDLC per site procedures\nSupport programming, configuration, commissioning, and validation of Rockwell and PharmaSuite platforms\nCollaborate with automation, IT, QA, and manufacturing teams\nSupport troubleshooting, root cause analysis, and deviation investigations as needed\nCommunicate effectively with stakeholders at all levels\n\nRequired Qualifications\n\n8+ years of experience in CSV and Automation within a regulated biotech/pharma environment\nHands-on experience with implementation, migration, and validation of:\nPCS (Rockwell and/or Honeywell)\nMES (PharmaSuite, POMSnet)\nSCADA/PLC systems\nStrong, hands-on expertise with Rockwell and PharmaSuite (required)\nIn-depth knowledge of:\nSDLC\n21 CFR Part 11 / Annex 11\nData Integrity\nComputerized System Validation (CSV)\nAbility to work independently and collaboratively in team environments\nExcellent verbal and written communication skills\n\nPreferred Qualifications\n\nFamiliarity with S88 Batch Standard\nExperience with Rockwell software object development\nMES recipe authoring and testing experience\n Experience with Kneat\n\nAdditional Information\n\nThis position requires 100% onsite support in California\nLong-term project opportunity in a regulated manufacturing environment\n\n#J-18808-Ljbffr","company":"Trinity Consultants","rawCompany":"trinity consultants","city":"Millbrae","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-11-04T05:00:52.036Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.05","title":"Mechatronics Engineers","slug":"mechatronics-engineers"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Automation CSV Engineer","description":"Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.\nADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.\nADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.\nThe successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.\nThis is an outstanding opportunity to join our growing team!\nPosition Overview\nWe are seeking an experienced Sr. Automation CSV Engineer to support a complex automation system migration project at a large, regulated biotechnology/pharmaceutical manufacturing site in the California Bay area. The ideal candidate will bring deep, hands-on expertise in PCS and MES system migration, validation, and implementation, with a strong preference for experience in Rockwell and PharmaSuite environments.\nThis role requires a senior-level engineer capable of independently executing and leading CSV and automation activities while collaborating closely with cross-functional teams.\nKey Responsibilities\n\nLead and execute CSV and automation activities for PCS/MES system migration projects\nSupport implementation, migration, commissioning, and validation of:\nPCS systems (Rockwell, Honeywell)\nMES systems (PharmaSuite, POMSnet)\nSCADA and PLC platforms\nAuthor, review, approve, and execute CSV lifecycle documentation, including:\nValidation Plans\nTest Protocols (IQ/OQ/PQ)\nTraceability Matrices\nValidation Summary Reports\nEnsure compliance with SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5\nManage and document software changes throughout the SDLC per site procedures\nSupport programming, configuration, commissioning, and validation of Rockwell and PharmaSuite platforms\nCollaborate with automation, IT, QA, and manufacturing teams\nSupport troubleshooting, root cause analysis, and deviation investigations as needed\nCommunicate effectively with stakeholders at all levels\n\nRequired Qualifications\n\n8+ years of experience in CSV and Automation within a regulated biotech/pharma environment\nHands-on experience with implementation, migration, and validation of:\nPCS (Rockwell and/or Honeywell)\nMES (PharmaSuite, POMSnet)\nSCADA/PLC systems\nStrong, hands-on expertise with Rockwell and PharmaSuite (required)\nIn-depth knowledge of:\nSDLC\n21 CFR Part 11 / Annex 11\nData Integrity\nComputerized System Validation (CSV)\nAbility to work independently and collaboratively in team environments\nExcellent verbal and written communication skills\n\nPreferred Qualifications\n\nFamiliarity with S88 Batch Standard\nExperience with Rockwell software object development\nMES recipe authoring and testing experience\n Experience with Kneat\n\nAdditional Information\n\nThis position requires 100% onsite support in California\nLong-term project opportunity in a regulated manufacturing environment\n\n#J-18808-Ljbffr","datePosted":"2026-11-04T05:00:52.036Z","dateModified":"2026-11-04T05:00:52.036Z","hiringOrganization":{"@type":"Organization","name":"Trinity Consultants","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Millbrae","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"84f65e39ca4e187b07bdb011"},"url":"https://jobsearcher.com/jobs/84f65e39ca4e187b07bdb011"}}