Controls System Software Engineer

Job Description OVERVIEW: The Control Systems Software Engineer is responsible for providing technical programming and commissioning support for Comecer equipment to our North American (NA) customers. Specifically, regarding the software aspects of Comecer systems including Siemens and Rockwell PLC/HMI, PCs, and other controls software utilized in Comecer solutions. Familiarity with Pharma would be a plus including knowledge of 21 CFR Part 11 compliance a plus Develop software according to job specifications Will participate and support the SAT, IQ/OQ and PQ activities for new installations This position will include activities for Radiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North America; including, but are not limited to: 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 Key Responsibilities Key Responsibilities: Software Analysis of project technical specifications Monitoring of the project objectives and the assigned team Drafting of the necessary documentation related to the various project phases Development of the software according to the specifications and the project Gantt chart Supervise and manage the team to achieve the required objectives Contributes to the choice of components, and to the definition of network architectures Participates in technical alignment meetings to discuss progress and issues After downloading the software on the machine, follows the testing and the FAT Once the machine is positioned and installed, follows the commissioning and the SAT During the development of the project, considers the following: verification of job critical issues evaluation of the project timeline search for solutions to unresolved technical problems request for operational resources proposals for standardization and/or improvement Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements Ensure products compliance with company and international quality standards Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities Other duties as…