Controls System Software Engineer

About the Role

The Control Systems Software Engineer provides 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 21 CFR Part 11 compliance, is a plus. This role supports projects in Radiopharma, Pharma, and Cell & Gene Therapy (ATMP), including:

• Radiopharma: Shielded hot cells, automation, synthesis and dispensing modules for vials and syringes, LAF shielded isolators, sterility testing isolators, VPHP generators, 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 lines 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

• Analyze project technical specifications.
• Monitor project objectives and assigned team progress.
• Draft documentation related to various project phases.
• Develop software according to specifications and project Gantt chart.
• Supervise and manage the team to achieve required objectives.
• Contribute to the choice of components and definition of network architectures.
• Participate in technical alignment meetings to discuss progress and issues.
• Follow software testing and Factory Acceptance Testing (FAT).
• Support commissioning and Site Acceptance Testing (SAT) after machine installation.
• Address job-critical issues, evaluate project timelines, and propose solutions to technical problems.
• Request operational resources and propose standardization or improvements.
• Support colleagues in drafting and finalizing technical documents.
• Ensure interpretation and application of legal, regulatory, and project requirements.
• Ensure product compliance with company and international quality standards.
• Verify product alignment with technical specifications and resolve non-conformities.
• Adhere to Health, Safety, and Environmental (HSE) requirements, including:
  • Working in compliance with divisional health, safety, and environmental procedures.
  • Reporting unsafe conditions, acts, or equipment defects.
  • Using required protective equipment for assigned tasks.
  • Attending required HSE training.
  • Reporting accidents/incidents and assisting in investigations.
• Perform other duties as assigned.

Requirements

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

Job Specifications

• May require standing, walking, pushing, pulling, reaching overhead, and bending.
• Visual acuity for reading instructions and computer screens.
• Hearing ability for understanding verbal instructions.
• Working conditions include a normal office environment with occasional exposure to high noise levels or physical hazards when visiting customer facilities.
• Capable of wearing appropriate personal protective equipment (PPE).