Control Systems Software Engineer

About the Role

Provide technical programming and commissioning support for Comecer equipment to North American customers, focusing on software aspects of Comecer systems including Siemens and Rockwell PLC/HMI, PCs, and other controls software. Familiarity with Pharma, including knowledge of 21 CFR Part 11 compliance, is a plus. This position supports Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) projects in North America.

• Radiopharma: Shielded hot cells and automation, synthesis and dispensing modules for vials and syringes, LAF shielded isolators, sterility testing isolators, VPHP generators for sterilization, solid target processing systems, dose calibrators, and VPHP sterilization modules
• Pharma: Aseptic handling and filling of liquid and powder APIs, dispensing custom R&D isolators, potent API processing isolators (PAPI), modular sterility testing isolators (MSTI), ATEX isolators, Baby Phill small batch vial filling, aseptic filling line for RTU vials, syringes, cartridges, fully automated combination product end-to-end filling systems, Speedy Glove™, SuperTrak™ Pharma Flow Fillers
• Cell & Gene Therapy (ATMP): Modular cell culture isolator (MCCI), incubation system for advanced therapy labs FlexyCult™, ValueCell Fill

Responsibilities

• Software analysis of project technical specifications
• Monitor project objectives and assigned team
• Draft documentation related to project phases
• Develop software according to specifications and project Gantt chart
• Supervise and manage the team to achieve objectives
• Contribute to the choice of components and definition of network architectures
• Participate in technical alignment meetings to discuss progress and issues
• Follow testing and FAT after software download
• Support commissioning and SAT during machine installation
• Verify job-critical issues and evaluate project timelines
• Search for solutions to unresolved technical problems
• Request operational resources and propose standardization/improvement
• Support colleagues in drafting and finalizing technical documents
• Interpret and apply legal, regulatory, and project requirements
• Ensure product compliance with company and international quality standards
• Take corrective action to resolve non-conformities
• Other duties as assigned

Health, Safety, & Environmental (HSE) Requirements

• Work in compliance with divisional health, safety, and environmental procedures
• Refrain from removing or altering safety devices or guarding unless hazardous energies are controlled through lockout-tagout methods
• Report any unsafe conditions or unsafe acts
• Report defects in equipment or protective devices
• Ensure required protective equipment is used for assigned tasks
• Attend all required health, safety, and environmental training
• Report any accidents/incidents to supervisor
• Assist in investigating accidents/incidents
• Refrain from engaging in pranks, contests, feats of strength, unnecessary running, or rough and boisterous conduct

Requirements

• Bachelor’s degree or post-secondary education in Automation Engineering, Computer Science, Electrical Engineering, or Electronics
• At least three years in controls engineering software
• Knowledge of PLC development environments, preferably Siemens (TiaPortal, Step7), Rockwell, B&R
• Knowledge of SCADA/HMI environments: Siemens WinCC TiaPortal, Movicon, Rockwell, B&R
• Knowledge of regulations applicable to Comecer products and certification processes
• Ability to work effectively with internal, cross-functional teams and customers under pressure
• Self-driven, attentive to detail, consistent, and process-driven
• Fluent in English (written and oral); fluency in Italian is an asset
• Excellent time-management skills and ability to coordinate multiple projects
• Proficient with Microsoft software tools (Outlook, Project, Word, Excel, PowerPoint)
• Must be eligible and able to travel domestically & internationally within 30 days from hire date and legally eligible to operate a vehicle

Job Specifications

• May be required to stand, walk, push, pull, reach overhead, and bend to the floor
• Visual Acuity: Normal requirements for reading written instructions and computer screens
• Hearing Ability: Normal requirements for understanding verbal instructions
• Working Conditions: Normal office environment with occasional exposure to high noise levels and/or physical hazards when visiting customer facilities; capable of wearing appropriate PPE