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:

1. verification of job critical issues
2. evaluation of the project timeline
3. search for solutions to unresolved technical problems
4. request for operational resources
5. 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 assigned.

HSE Requirements

HEALTH, SAFETY, & ENVIRONMENTAL (HSE) REQUIREMENTS:

All employees have the responsibility to work in a safe manner and report any health, safety, or environmental concern to their manager or supervisor in a timely manner.

Employee responsibilities for Health, Safety and Environment include:

• 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 defect in any equipment or protective device
• Ensure that the required protective equipment is used for the 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 any prank, contest, feat of strength, unnecessary running or rough and boisterous conduct

Qualifications

Qualifications:

• 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 according to deadlines and under pressure-filled conditions.
• Self-driven, attentive to detail, consistent, and process driven.
• Fluent in English, written and oral, fluent in Italian is an asset
• Excellent time-management skills and ability to efficiently coordinate multiple projects at a time.
• Proficient with Microsoft software tools including Outlook, Project, Word, Excel, and Power Point
• Must be eligible and able to travel domestically & internationally within 30 days from hire date and legally eligible to operate a vehicle, as this is an essential job function.

Job Specifications

JOB SPECIFICATIONS:

• The employee 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 – The employee is subject to a normal office environment with occasional exposure to high noise levels and/or physical hazards when visiting customer facilities.
• Capable of wearing appropriate related PPE