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 lead Critical and Plant Utility projects from inception to completion.

Responsibilities

Provides engineering support throughout manufacturing facilities in process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation; 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; Establishes and streamlines practices around equipment and/or facility specification, design, start-up, and commissioning & qualification; Prepares URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents; Prepares and executes factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of Facilities, Systems, Utilities and Equipment; Procures new equipment, creates and maintains appropriate engineering records; Works closely with support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control; Supports execution of start-up and commissioning activities on equipment, utility and GMP manufacturing Facilities, Systems, Utilities and Equipment

Requirements

BS in Chemical, Mechanical, or other Engineering degree from an accredited university; A minimum of 5 plus years’ experience in engineering, facilities clean utilities and/or plant utilities; Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles; GMP and non-GMP change control, maintaining regulatory compliance; Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system; Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes; Strong organization, interpersonal, oral and good written communication skills; Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point; 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

Nice to have

preferably in the biotechnology, medical device or pharmaceutical industry; 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 a Plus; Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus