{"id":4069388,"url":"https://alion.io/job/lonza-controls-engineer-level-3","title":"Controls Engineer, Level 3","company":{"id":679681,"name":"Lonza","domain":"lonza.com","url":"https://alion.io/company/lonza","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":72,"ghost_share":0,"stale_share":0.639,"repost_share":0,"time_to_fill_p50_days":41,"computed_at":"2026-11-12T10:38:37Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Portsmouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-11T12:53:27Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-12T08:06:05Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Senior Automation, Instrumentation & Controls Engineer\nPortsmouth NH\n1st shift Mondy - Friday 8am - 5pm\nToday, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.\nThe Role\nLonza is seeking a highly experienced Senior Automation, Instrumentation & Controls Engineer to provide technical leadership for complex GMP automation, instrumentation, and process control systems supporting commercial biopharmaceutical manufacturing operations. This role serves as a key Controls Subject Matter Expert (SME), leading technical investigations, system enhancements, capital projects, and technology transfers while ensuring compliance, reliability, and operational excellence across site manufacturing systems.\nThe successful candidate will establish technical direction for complex automation initiatives, collaborate across Manufacturing, Quality, Engineering, Validation, and MSAT functions, and play a critical role in enhancing site capabilities through system reliability improvements, compliant engineering practices, and mentorship of developing engineers.\nKey Responsibilities\nTechnical Leadership & System Ownership\nProvide senior technical leadership and oversight for GMP automation, instrumentation, and control systems supporting manufacturing operations.\nLead complex technical support, reliability improvement, and lifecycle management activities across assigned manufacturing processes and controls platforms.\nEstablish technical approaches and engineering strategies for ambiguous or complex assignments requiring independent judgment and risk-based decision making.\nServe as the primary Controls SME for Manufacturing, MSAT, Engineering, Quality, and project teams.\nAutomation & Controls Engineering\nLead the design, implementation, testing, and deployment of complex automation changes involving:Emerson DeltaV Distributed Control Systems (DCS)\nPLC-based control systems\nProcess instrumentation and field devices\nI/O architectures and communication networks\nOPC/Kepware interfaces\nBatch reporting and data collection systems\n\nOwn complex control system modifications and provide technical review and approval of engineering documentation, including P&ID updates and work orders.\nDevelop and approve automation strategies that balance manufacturing needs, system reliability, lifecycle sustainability, and regulatory compliance.\nProjects & Technology Transfers\nLead Controls and Automation scope for capital projects, process expansions, and technology transfer activities.\nDevelop project estimates, schedules, resource plans, risk assessments, and contractor management strategies.\nCoordinate cross-functional activities to ensure successful implementation and startup of automation-related projects.\nDrive stakeholder alignment while managing competing project priorities.\nTroubleshooting & Investigations\nLead high-complexity troubleshooting efforts across manufacturing systems and control platforms.\nUtilize historian data (OSIsoft PI), code reviews, configuration assessments, root cause analysis methodologies, and cross-functional investigations to identify and resolve system issues.\nAssess process and automation risks and recommend corrective and preventive actions to prevent recurrence.\nSupport manufacturing operations during critical events and participate in site on-call support activities.\nCompliance & Validation\nAuthor, review, and approve:Functional Specifications (FS)\nDesign Specifications (DS)\nConfiguration Specifications\nTest Protocols\nValidation Documentation\n\nDefine testing strategies and lead FAT, SAT, commissioning, startup, and validation-support activities.\nOwn and approve quality records including deviations, CAPAs, investigations, and change controls.\nEnsure documentation is completed within Kneat, TrackWise, DMS, and Veeva systems in accordance with site procedures and regulatory requirements.\nEnsure compliance with:GAMP 5\nISA-88\n21 CFR Part 11\nEU Annex 11\nApplicable GMP regulations and corporate standards\n\nCollaboration & Mentorship\nRepresent Controls Engineering in governance forums, Integrated Project Teams (IPTs), Joint Project Teams (JPTs), customer discussions, client audits, and regulatory inspections.\nProvide technical mentoring and coaching to automation and controls engineers.\nLead technical reviews, establish engineering standards, and share lessons learned across the organization.\nProvide direction and oversight to contractors, integrators, and project resources.\nRequired Qualifications\nEducation\nBachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Chemical Engineering, Computer Engineering, or related technical discipline.\nExperience\nSignificant experience supporting GMP manufacturing automation and process control systems within the biopharmaceutical, pharmaceutical, biotechnology, or regulated manufacturing industry.\nDemonstrated experience leading complex controls engineering projects and technology transfers.\nStrong experience with DeltaV, PLCs, process instrumentation, and industrial automation systems.\nProven success leading technical investigations, root cause analysis activities, and complex troubleshooting efforts.\nExperience supporting commissioning, qualification, validation, and startup activities within regulated environments.\nTechnical Knowledge\nExpertise in automation system architecture, process control strategies, and manufacturing execution environments.\nStrong understanding of GMP regulations and computerized system compliance requirements.\nExperience with PI Historian, change management systems, and electronic quality management platforms.\nKnowledge of process instrumentation, networking, industrial communications, and batch control systems.\nFamiliarity with risk assessment methodologies and lifecycle management principles.\nEvery Day, Lonza's Products and Services Have a Positive Impact on Millions of People.\nFor us, this is not only a privilege but also a great responsibility. We look for individuals who are driven by improving patient outcomes, committed to operational excellence, and eager to contribute to a culture of innovation, collaboration, and continuous improvement.\nCome grow with us and make a meaningful difference.\nLonza is an equal opportunity employer. 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