Senior Engineer, Automation

Role Summary

The Senior Engineer, Automation will join the Process Automation team at the Next Generation Biologics (NGB) facility in Rahway, NJ. The role supports design of the DeltaV automation system, provides automation support during facility startup and ongoing operations, and contributes to continuous improvement projects to enable flexible, multi-product GMP manufacturing for biologics.

Responsibilities

• Provide key automation support for various manufacturing systems such as DCS (DeltaV), PLC, MES, SCADA and OEM systems
• Work with process development teams on technical development and the testing of new technologies, trialing new automation strategies, and implementing them in the GMP areas
• Support capital projects, design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off shift work may be required to meet project, operations, and qualification needs.
• Execute and develop appropriate system validation, change control, and testing documentation in partnership with project CQV and IT teams.
• Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems.
• Lead integration of control systems with MES, Quality, and Batch Reporting applications.
• Understand and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.
• Support and/or Direct Continuous Improvement projects with automation review of equipment specifications, P&IDs, and System Life Cycle documentation
• Responsible for troubleshooting challenging equipment/automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP
• Lead automation related investigations into deviations and implement the corrective actions
• Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed

Qualifications

• Required: Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 4 years relevant experience, or a master’s degree with minimum years of relevant experience.
• Required: DeltaV experience, including Control Studio, and the completion of a DeltaV training course (such as Course 7009)
• Preferred: At least 4 years of experience in an Automation or Engineering function for Biologics, Food, Medical Devices, or Pharmaceutical industries
• Preferred: Proven experience with development and implementation of industrial controls such as DCS (Delta V), SCADA (Wonderware, iFix), PLC applications (Siemens, Allen Bradley), Historian (PI)
• Preferred: I/O Networking experience (Ethernet/IP, OPC, Profinet, ControlNet, Profinet, DeviceNet, and ModBus protocols) is advantageous
• Preferred: Working experience with GAMP, S88 and other industry standards.
• Preferred: Commissioning and qualification test protocol development and execution
• Preferred: Track record of working effectively with team-members of diverse skill sets and backgrounds
• Preferred: Strong presentations and verbal/written communication skills
• Preferred: Experienced in the administration of GMPs, Good Documentation Practices (GDPs), and S&E regulations as it pertains to biologics development
• Preferred: Excellent attention to detail, highly independent with initiative
• Preferred: Excellent troubleshooting and problem-solving skills

Skills

• Accountability
• Adaptability
• Analytical Testing
• Automation
• Clinical Trials
• Communication
• Data Analysis
• Detail-Oriented
• Deviation Management
• Equipment Qualification
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Immunochemistry
• Manufacturing Compliance
• Manufacturing Processes
• Microbiology
• New Product Development
• Pharmaceutical Sciences
• Process Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Proper Documentation
• Regulatory Compliance
• Regulatory Requirements

Education

• Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline; or master’s degree with minimum years of relevant experience.

Additional Requirements

• Travel: 10%