PLANT ENGINEER I/ II/ III

Summary

The Plant Engineer II 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 conceptual, basic and detailed design, procurement, installation and start‑up for new plant facilities, equipment, utilities and systems. Acts as a Change Agent to drive innovation and operational effectiveness. Engages with functional department leaders to understand equipment capability and capacity requirements, and ensures inclusion of existing site facility and engineering team members in the learning and design processes 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.

Essential Duties and Responsibilities

• 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 engineering 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 skillfully; develop alternative solutions; 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, specifications 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, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure PCI assets are well engineered and maintained throughout their lifecycles.
• Prepare and execute factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of FSUE.
• Procure new equipment and maintain appropriate engineering records, including equipment manuals, drawings, diagrams, and inspection reports per Good Engineering policies.
• Support execution of start‑up and commissioning activities on equipment, utilities and GMP manufacturing facilities, systems, utilities and equipment.

Qualifications

• BS in Chemical, Mechanical, or other Engineering discipline from an accredited university.
• Minimum of 9+ years of experience in engineering, clean utilities, or plant utilities, preferably in biotechnology, medical device, or pharmaceutical industry.
• Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles.
• Experience with GMP and non‑GMP change control and maintaining regulatory compliance.
• Experience with aseptic liquid filling of vials, CIP/SIP, clean rooms, lyophilization, and aseptic processes (including refrigerated and frozen capabilities) – a plus.
• Proficiency with Computerized Maintenance Management Systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control systems.
• Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices – a plus.
• Demonstrated proficiency in applying basic manufacturing, engineering, and 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.