Plant Engineer III

The Plant Engineer III provides engineering support throughout the various manufacturing facilities in areas such as process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation. Demonstrates good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources. Supports the review, and approval of the conceptual, basic and detailed design, procurement, installation and start-up for new plants facilities, equipment, utilities and systems.

Engages with functional department leaders to establish an understanding of the needs/requirements of the department from an equipment capability and capacity perspective. Ensures inclusion of existing site facility and engineering team members in the learning process and design process for new plant systems. Systems include water pretreatment, generation of WFI, plant steam, Clean Steam, Clean Air, Clean Gases, Plant HVAC, Fill Finish equipment and lyophilization.

Independently leads Critical and Plant Utility projects from inception to completion.

• Support safety through personal engagement and promote individual accountability for safety within the Plant Engineering Department.
• Ensure risks to employee health and safety are rigidly controlled and conduct all activities in accordance with cGMP, EH&S, and site quality systems.
• Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning & qualification.
• Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation of IQ/OQ protocols, executions, and summary reports.
• Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout.
• Design and execute engineering runs to test equipment or troubleshoot problems.
• Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment.
• Identify and resolve problems in a timely manner, gather and analyze information, develop alternative solutions, and work well in group problem solving situations.
• Provide technical support for users regarding investigations, recurring problems, required modifications, optimizations, and continuous improvements.
• Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform factory/site acceptance testing.
• Prepare URS, ETOPs, risk assessments, safety assessments and other engineering documents associated with FSUE as required.
• Execute good engineering practices for new equipment, systems and utilities as applicable.
• Collaborate closely with support groups such as MTS, Automation, Manufacturing, QA, Facility Ops & Maintenance, Metrology, Engineering, EHS&S, and QC to ensure assets are engineered and maintained throughout their life cycles.
• Prepare and execute factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of FSUE.
• Procure new equipment and create/maintain appropriate engineering records, manuals, drawings/diagrams, inspection reports per Good Engineering policies.
• Support start-up and commissioning activities on equipment, utilities and GMP manufacturing facilities, systems, utilities and equipment.

• BS in Chemical, Mechanical or other Engineering degree from an accredited university.
• Minimum of 5+ years’ experience in engineering, facilities clean utilities and/or plant utilities, preferably in biotechnology, medical device or pharmaceutical industry.
• Strong understanding of technical project management, Good Engineering Practices, reliability and Lean Principles, GMP and non-GMP change control, maintaining regulatory compliance.
• Experience with aseptic liquid filling of vials, CIP/SIP and Clean Room, lyophilization, aseptic filling of vials and aseptic processes, including refrigerated and frozen capabilities.
• Experience with CMMS, AutoCAD, Solid Works, PLC & SCADA control system.
• Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices.
• Demonstrated proficiency in applying basic manufacturing, engineering and/or scientific theories, principles and techniques used in biopharmaceutical manufacturing processes.
• Strong organization, interpersonal, oral and written communication skills.
• Proficiency with standard software applications, including MS Word, MS Excel, MS Project and MS PowerPoint.
• Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.
• Effectively support internal and external relationships, key stakeholders and vendors.
• Excellent understanding of team and group dynamics.
• Demonstrated agility to working in a fast-paced CMO environment.
• Excellent technical writing abilities.