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Controls Engineer

Sterling Engineering, Inc.

Noblesville, IN

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JOB DETAILS
SKILLS
Application Programming Interface (API), Asepsis, Automation, Automation Engineering, Automation Systems, Biotech and Pharmaceutical, Calibration, Cell Cultures, Code of Federal Regulations, Commissioning, Component Selection, Computer Science, Control Engineering, Control Systems, Corporate Compliance, Corrective Action, Cross-Functional, Debugging Skills, Detail Oriented, Documentation, Documentation Standards, Electrical Engineering, Electricity, Electronic Engineering, Electronics, Engineering Software, English Language, Gene Therapy, Human Machine Interface (HMI), Italian Language, Legal, Maintain Compliance, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Multitasking, Network Architecture/Engineering, Organizational Skills, PC Software, Physical Demands, Problem Solving Skills, Process Validation, Programmable Logic Controller (PLC), Project Commissioning, Project Development, Project Evaluation, Project Tracking, Project/Program Coordination, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Safety Process, Safety Training, Safety/Work Safety, Software Administration, Software Development, Software Engineering, Software Specification, Staff Requirements, Sterilization, Supervisory Control and Data Acquisition (SCADA), Systems Engineering, Team Lead/Manager, Team Player, Technical Analysis, Technical Drawing, Technical Support, Technical Writing, Time Management, Variable Costs, Willing to Travel
LOCATION
Noblesville, IN
POSTED
30+ days ago
Position Title: Control Systems Software Engineer Global Job Code: ENS.03.016.P20 Department: Service Cost Code: Direct Reports To: Solutions Engineering Supervisor Travel: 0% - 50% 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: 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 COMECER Inc. (an ATS company) 5521 Meadowbrook Industrial Ct. Rolling Meadows, IL 60008 Phone: +1 847-925-1238 | serviceamerica@comecer.com www.comecer.com • 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. 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: • 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 2 COMECER Inc. (an ATS company) 5521 Meadowbrook Industrial Ct. Rolling Meadows, IL 60008 Phone: +1 847-925-1238 | serviceamerica@comecer.com www.comecer.com • 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: • 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 This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice. _______________________________________________ _____________________ Signature Date 3 COMECER Inc. (an ATS company) 5521 Meadowbrook Industrial Ct. Rolling Meadows, IL 60008 Phone: +1 847-925-1238 | serviceamerica@comecer.com www.comecer.com Control Systems Software Engineer Location: North America (mostly Indiana)Employment Type: Direct HirePay: $40–45/hr + OT after 45 hoursTravel: ~30% domestic Overview We are seeking a Control Systems Software Engineer to provide programming and commissioning support for equipment across North America. This role focuses on software aspects including Siemens & Rockwell PLC/HMI, PCs, and controls software. Bonus: Pharma experience and knowledge of 21 CFR Part 11 compliance. Key Responsibilities Software Development & Project Support Develop software per project specifications Participate in SAT, IQ/OQ, and PQ for new installations Support Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) projects Draft and maintain project documentation Monitor project objectives and team performance Contribute to network architecture and component selection Conduct testing, FAT, and on-site commissioning Project & Quality Management Verify job-critical issues and project timelines Solve technical problems and request resources as needed Ensure product compliance with internal and international standards Assist colleagues in documentation and regulatory compliance Other duties as assigned Health, Safety & Environment Follow all HSE procedures Use proper PPE and report unsafe conditions Participate in HSE training and incident investigations Projects You’ll Work On Radiopharma Shielded hot cells, automation systems, synthesis/dispensing modules LAF shielded isolators, sterilization systems Pharma Aseptic filling of liquid/powder APIs Potent API processing isolators (PAPI) Automated combination product filling systems Cell & Gene Therapy (ATMP) Modular cell culture isolators (MCCI) FlexyCult™ incubation systems, ValueCell Fill systems Qualifications Bachelor’s degree or post-secondary in Automation, Computer Science, Electrical, or Electronics 3+ years in controls engineering software PLC knowledge: Siemens (TIA Portal, Step7), Rockwell, B&R SCADA/HMI: Siemens WinCC, Movicon, Rockwell, B&R Familiarity with regulatory requirements and certification processes Strong teamwork, time management, and project coordination Self-driven, detail-oriented, process-focused Fluent in English; Italian is a plus Proficient with Outlook, Project, Word, Excel, PowerPoint Able to travel domestically & internationally within 30 days of hire Physical Requirements Stand, walk, push/pull, reach overhead, bend Normal vision and hearing for office/computer work Exposure to noise/physical hazards at customer sites

About the Company

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Sterling Engineering, Inc.

Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:

 

  • Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.

 

  • Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.

 

Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1969
WEBSITE
http://www.sterling-engineering.com

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