Automation Engineer

Title: Engineer II, Automation

Location: Pittsburgh

Reports to: Director Facilities & Engineering

The Client is a technology-driven cell and gene therapy organization, accelerating access to cutting-edge technologies and expertise to change the future of medicine. Its integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

The Client is looking for an Automation Engineer II who will play a key role in owning the Client facilities controls and automation systems (Systems). For these Systems, this role will develop support models to ensure robust operations, manage vendor and software support contracts, provide key support for various manufacturing, quality, and research automated systems, support capital projects for facility expansion, ensure new assets are integrated into the automation infrastructure, troubleshoot and support manufacturing operations equipment, and work closely with the Quality and Validation teams to ensure compliance and that the systems are ready for use.

The Automation Engineer II will be successful in their responsibilities by owning the Systems and being a team player who thrives on delivering value to the customer. This individual should have strong technical knowledge and experience in a variety of facility controls & infrastructure (e.g. BMS, BAS, BacNet, MTPS), automation systems & infrastructure (e.g. SCADA, PLCs, HMIs, Data Historian, etc.), regulatory requirements (e.g. 21 CFR Part 11, Annex 11, Data Integrity, etc.), a passion for learning, and a willingness to dive into the details to solve problems.

Robust, lean automation and data collection for processes are critical to achieving the Client’s strategy for quickly launching next-generation cell and gene therapies for patients.

Here’s What You’ll Do:

• Manage control and automation systems projects through the full project life cycle and ensure systems are maintained in a compliant state post go-live
• Work closely with Facilities, Engineering, MSAT, and Operations teams to support projects and operational needs
• Troubleshoot facilities control systems, automation systems, or related infrastructure to improve manufacturing performance while maintaining cGMP compliance
• Provide configuration, development, and break/fix day-to-day support of automation systems
• Manage automation system documentation and SOPs; prepare technical and user documentation; conduct system training
• Lead automation-related investigations into Quality Event Reports and implement corrective actions
• Lead system maintenance and manage the automation life cycle (application patching reviews, test plans, and execution of test scripts)
• Coordinate with business users to develop reports (batch, material, audit trails, etc.) supporting efficient operations
• Manage automation contractors supporting projects, daily operations, and planned/unplanned maintenance while ensuring adherence to safety and quality systems

Requirements:

• Bachelor’s degree in Engineering, Science, or a related technical field
• 6+ years of experience in a life sciences regulated environment (e.g. FDA) with working knowledge of pharmaceutical regulatory requirements
• 4+ years of experience integrating/interfacing equipment to control systems via OPC, Ethernet/IP, etc.
• Experience with PLCs (e.g. Allen Bradley & Siemens), SCADA (e.g. Ignition), Batch Operations (S88/S95), OSIsoft PI Historian, BMS/BAS (e.g. Siemens Desigo)
• Control panel and automation hardware/infrastructure design experience
• Demonstrated knowledge of 21 CFR Part 11, Annex 11, and GAMP 5
• Experience working in a pharmaceutical manufacturing environment, including gowning; aseptic operations experience preferred