{"schemaVersion":"jobsearcher.job.v1","id":"5f356f8aa383d05a2d7ceed8","url":"https://jobsearcher.com/jobs/5f356f8aa383d05a2d7ceed8","canonicalUrl":"https://jobsearcher.com/jobs/5f356f8aa383d05a2d7ceed8","title":"Process Engineer","description":"Process Engineer Job Summary & Responsibilities Job Summary:\nThe position works in partnership with maintenance, process development, project management, technical engineering authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities.\nBe individually accountable for the deliverables on projects.\nIdentify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.\nDevelop and present project charters/strategies to leadership.\nDeveloping accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.\nLeads the team effectiveness by: identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items; following appropriate escalation process.\nAssist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.\nAssist in development and review of User Requirements Specifications (URS).\nIdentify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.\nPartner with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).\nRecommend, evaluate, and manage performance of contract resources.\nProvide oversight for verification deliverables developed by outsourced/contract verification staff.\nAct as a liaison between cross-functional teams during project planning, execution, and closeout.\nEnsure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.\nEnsure safety during commissioning, validation, maintenance and manufacturing activities.\nSupport Manufacturing and QA with Performance Qualification (PQ) activities if applicable.\nPreferred Qualifications / Skills / Experience Bachelor\\'s degree in engineering or other science-related field\n7 or more years of relevant work experience in operations/manufacturing environment\n5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated chemical manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)\nDirect experience working within regulated environments (FDA, OSHA, EPA, etc.)\nWorking knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment\nExperience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution\nUnderstanding and awareness of industry/regulatory trends for verification/validation\nStrong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging\nStrong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification\nKnowledge of Delta V, Rockwell, and Plant Information Systems is a plus\nDemonstrated strong communication and technical writing skills\nStrengths in facilitation and collaboration / networking\nExperience in developing SOPs and delivering training\nIndividual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making\nProven track record of applying process improvement methodologies to mature and improve business processes (e.g., PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)\n\n#J-18808-Ljbffr","company":"Trinity Consultants","rawCompany":"trinity consultants","city":"Millbrae","state":"CA","isRemote":false,"isActive":true,"createdAt":"2026-06-20T04:44:29.724Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-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":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Process Engineer Job Summary & Responsibilities Job Summary:\nThe position works in partnership with maintenance, process development, project management, technical engineering authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities.\nBe individually accountable for the deliverables on projects.\nIdentify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.\nDevelop and present project charters/strategies to leadership.\nDeveloping accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.\nLeads the team effectiveness by: identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items; following appropriate escalation process.\nAssist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.\nAssist in development and review of User Requirements Specifications (URS).\nIdentify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.\nPartner with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).\nRecommend, evaluate, and manage performance of contract resources.\nProvide oversight for verification deliverables developed by outsourced/contract verification staff.\nAct as a liaison between cross-functional teams during project planning, execution, and closeout.\nEnsure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.\nEnsure safety during commissioning, validation, maintenance and manufacturing activities.\nSupport Manufacturing and QA with Performance Qualification (PQ) activities if applicable.\nPreferred Qualifications / Skills / Experience Bachelor\\'s degree in engineering or other science-related field\n7 or more years of relevant work experience in operations/manufacturing environment\n5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated chemical manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)\nDirect experience working within regulated environments (FDA, OSHA, EPA, etc.)\nWorking knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment\nExperience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution\nUnderstanding and awareness of industry/regulatory trends for verification/validation\nStrong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging\nStrong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification\nKnowledge of Delta V, Rockwell, and Plant Information Systems is a plus\nDemonstrated strong communication and technical writing skills\nStrengths in facilitation and collaboration / networking\nExperience in developing SOPs and delivering training\nIndividual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making\nProven track record of applying process improvement methodologies to mature and improve business processes (e.g., PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:44:29.724Z","dateModified":"2026-06-20T04:44:29.724Z","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":"5f356f8aa383d05a2d7ceed8"},"url":"https://jobsearcher.com/jobs/5f356f8aa383d05a2d7ceed8"}}