Control Systems Software Engineer

Location: Greater Indianapolis Area (Home office located in Noblesville IN)

Travel Requirement: Travel up to 30%

Salary Range: $95000 - $120000

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:

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. 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.

Qualifications:

• Bachelors 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.