Plant Engineer III

PCI Pharma Services•Bedford, NH

About The Position

The Plant Engineer III provides engineering support across manufacturing facilities, including process equipment improvements, technology advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, and safety and environmental compliance. The role collaborates with internal and external partners and supports review and approval of conceptual, basic, and detailed design, procurement, installation, and startup for plants, facilities, equipment, utilities, and systems. The engineer works with department leaders to understand equipment capability and capacity requirements and includes site facility and engineering team members in the learning and design processes for new plant systems. Systems include water pretreatment, water-for-injection generation, plant and clean steam, clean air and gases, plant HVAC, fill-finish equipment, and lyophilization. The position independently leads critical and plant utility projects from inception through completion. The role supports engineering execution and lifecycle management for facilities, systems, utilities, and equipment (FSUE), including specifications, design, procurement, fabrication, installation, commissioning, qualification, startup, and closeout. It develops and executes engineering runs, troubleshooting, testing, factory and site acceptance testing, and validation activities, and prepares associated engineering records and documentation. The engineer works with end users, contractors, and cross-functional groups to resolve technical issues, support investigations and continuous improvement, and ensure assets are engineered and maintained in accordance with good engineering practices, cGMP, EH&S, and site quality systems.

Requirements

Bachelor of Science in Chemical, Mechanical, or another engineering discipline from an accredited university.
At least 5 years of experience in engineering, facilities clean utilities, and/or plant utilities.
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 computerized maintenance management systems (CMMS), AutoCAD, SolidWorks, and PLC and SCADA control systems.
Demonstrated proficiency applying basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
Strong organization, interpersonal, oral communication, 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.
Ability to support internal and external relationships, key stakeholders, and vendors effectively.
Excellent understanding of team and group dynamics.
Ability to work in a fast-paced CMO environment.
Excellent technical writing abilities.

Nice To Haves

Experience in the biotechnology, medical device, or pharmaceutical industry.
Experience with aseptic liquid filling of vials, CIP/SIP, clean rooms, lyophilization, aseptic processes, and refrigerated and frozen capabilities.
Experience working in a GMP and FDA-regulated environment for drugs and/or medical devices.

Responsibilities

Promote safety and individual accountability within the Plant Engineering Department, control risks to employee health and safety, and conduct activities in accordance with cGMP, EH&S, and site quality systems.
Establish and streamline practices for equipment and facility specification, design, startup, commissioning, and qualification.
Coordinate fabrication, procurement, installation, engineering startup, and validation of new equipment and systems, including IQ/OQ protocols, execution, and summary reports.
Provide engineering support for FSUE projects and assignments from initial concept through final closeout.
Design and execute engineering runs to test equipment and troubleshoot problems.
Partner with contractors to troubleshoot issues in the manufacturing environment.
Identify and resolve problems, analyze information, develop alternative solutions, and provide technical support for investigations, recurring problems, modifications, optimization, and continuous improvement.
Work with end users to develop system requirements and equipment or building specifications; support fabrication and perform Factory/Site Acceptance Testing.
Prepare URS, ETOPs, risk assessments, safety assessments, and other engineering documents for FSUE as required.
Apply good engineering practices to new equipment, systems, and utilities.
Collaborate with MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure assets are well engineered and maintained throughout their lifecycles.
Prepare and execute FAT, SAT, setup, and commissioning of FSUE.
Procure new equipment and create and maintain engineering records, including equipment records and manuals, drawings and diagrams, and inspection reports.
Support startup and commissioning activities for equipment, utilities, and GMP manufacturing FSUE.