~30% domestic OverviewWe are seeking a Control Systems Software Engineer to provide programming and commissioning support for equipment across North America. This role focuses on software aspects including Siemens & Rockwell PLC/HMI, PCs, and controls software.
Bonus:
Pharma experience and knowledge of 21 CFR Part 11 compliance. Key ResponsibilitiesSoftware Development & Project SupportDevelop software per project specificationsParticipate in SAT, IQ/OQ, and PQ for new installationsSupport Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) projectsDraft and maintain project documentationMonitor project objectives and team performanceContribute to network architecture and component selectionConduct testing, FAT, and on-site commissioningProject & Quality ManagementVerify job-critical issues and project timelinesSolve technical problems and request resources as neededEnsure product compliance with internal and international standardsAssist colleagues in documentation and regulatory complianceOther duties as assignedHealth, Safety & EnvironmentFollow all HSE proceduresUse proper PPE and report unsafe conditionsParticipate in HSE training and incident investigationsProjects You'll Work OnRadiopharmaShielded hot cells, automation systems, synthesis/dispensing modulesLAF shielded isolators, sterilization systemsPharmaAseptic filling of liquid/powder APIsPotent API processing isolators (PAPI)Automated combination product filling systemsCell & Gene Therapy (ATMP)Modular cell culture isolators (MCCI)FlexyCult™ incubation systems, ValueCell Fill systemsQualificationsBachelor's degree or post-secondary in Automation, Computer Science, Electrical, or Electronics3+ years in controls engineering softwarePLC knowledge: Siemens (TIA Portal, Step7),
Rockwell, B&RSCADA/HMI:
Siemens WinCC, Movicon, Rockwell, B&RFamiliarity with regulatory requirements and certification processesStrong teamwork, time management, and project coordinationSelf-driven, detail-oriented, process-focusedFluent in English; Italian is a plusProficient with Outlook, Project, Word, Excel, PowerPointAble to travel domestically & internationally within 30 days of hirePhysical RequirementsStand, walk, push/pull, reach overhead, bendNormal vision and hearing for office/computer workExposure to noise/physical hazards at customer sites