Location: REMOTE in the Greater Indinanapolis Area
Travel: Up to 50% (including domestic and international)
Schedule: May include evenings and weekends due to embedded customer support
Salary Range: $95,000 - $120,000
Comecer is a global leader in advanced containment and automation technologies for the Radiopharma, Pharma, and Cell & Gene Therapy (ATMP) industries. Our innovative solutions include shielded isolators, aseptic filling systems, and modular cleanroom technologies that support cutting-edge research and production environments. We are committed to quality, compliance, and customer satisfaction across all our product lines.
Position Summary
We are seeking a Control Systems Software Engineer to provide technical programming and commissioning support for Comecer equipment across North America. This role focuses on the software aspects of our systems, including Siemens and Rockwell PLC/HMI, PC-based controls, and other automation platforms. You’ll play a key role in supporting installations, validations, and ensuring compliance with industry standards.
Note: This is an embedded role supporting our customer directly, and may require working evenings and weekends to meet project and operational needs.
Key Responsibilities
- Develop and implement control system software based on project specifications and timelines.
- Participate in SAT, IQ/OQ, and PQ activities for new installations.
- Analyze technical specifications and contribute to component selection and network architecture design.
- Draft and maintain documentation throughout project phases.
- Lead or support software testing, FAT, commissioning, and SAT on-site.
- Collaborate with cross-functional teams and customers to resolve technical issues and ensure project success.
- Ensure compliance with 21 CFR Part 11 and other applicable regulations.
- Support continuous improvement and standardization efforts.
- Assist in interpreting and applying legal, regulatory, and quality requirements.
- Other duties as assigned.
Qualifications
- Bachelor’s degree in Automation Engineering, Computer Science, Electrical Engineering, or related field.
- Minimum 3 years of experience in controls engineering software.
- Proficiency in PLC development environments: Siemens (TiaPortal, Step7), Rockwell, B&R.
- Experience with SCADA/HMI platforms: Siemens WinCC, Movicon, Rockwell, B&R.
- Familiarity with pharmaceutical environments and 21 CFR Part 11 compliance is a plus.
- Strong documentation and time-management skills.
- Fluent in English (written and verbal); Italian is a plus.
- Proficient in Microsoft Office tools (Outlook, Project, Word, Excel, PowerPoint).
- Must be legally eligible to travel and operate a vehicle.
Industries You’ll Support
- Radiopharma: Hot cells, dispensing modules, sterility testing isolators, VPHP sterilization systems.
- Pharma: Aseptic filling, potent API isolators, sterility testing, ATEX isolators, Baby Phill small batch fillers.
- Cell & Gene Therapy (ATMP): Modular cell culture isolators, FlexyCult™ incubation systems, ValueCell Fill.
Why Join Comecer?
- Work on cutting-edge technologies in life sciences and advanced therapies.
- Collaborate with global teams and industry leaders.
- Be part of a mission-driven company focused on innovation and compliance.
- Competitive compensation and travel opportunities.
Ready to engineer the future of pharma automation?
Apply today and bring your expertise to a global leader in containment and control systems.
Take your place among the best in the business, and grow your career with Comecer . Join an environment where a passion for innovation combines with an uncompromised commitment to quality. Join the Winning Team at Comecer, an ATS Automation company, a great place to automate your future!