Plant Engineer II

Plant Engineer II

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**The client is not offering sponsorship or C2C at this time**

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. Demonstrate leadership, effective collaboration, partnering and teamwork skills when interacting with internal and external resources. Support technical oversight, review, and approval of the conceptual, basic and detailed design, procurement, installation and start-up for new plant utility/facility systems. Ensure 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 High Purity Water systems, plant steam, Clean Steam, Clean Air, Clean gases, Plant HVAC, Fill Finish equipment Lyophilizers (Freeze dryers) CIP/SIP, fermenters and skids design for production and utilities.

Ability to lead Critical and Plant Utility projects from inception to completion. Responsible for safety and compliance risk management pertinent to Critical and Plant Utilities Projects. Assists with other facility related projects as assigned.

Responsibilities

• Support safety through personal engagement and promote individual accountability for safety within the Engineering Department. Ensure risks to employee health and safety are rigidly controlled in compliance with the EHS procedures.
• Provide support for Facilities, Systems, Utilities and Equipment (FSUE), management and execution of projects/assignments from initial concept to final closeout.
• Ensure projects cGMP documentation are in compliance. These documents include URS, FRS and submittals to support commissioning and validation processes. Proficiency with process instrumentation, P&IDs, valve selection, and identifying risks and opportunities for improving equipment/systems quality and process robustness.
• Lead, engage, motivate and positively influence others in the pursuit of achieving goals and objectives.
• Work with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors as needed, overseeing fabrication and leading Factory/Site Acceptance Testing.
• Participate in long-term strategic development of site Facilities, Systems, Utilities and Equipment.
• Support Capital projects, plant expansions and upgrades as needed. Assists in deviation investigations and develop resolutions for problems and issues encountered for Facilities, Systems, Utilities and Equipment (FSUE).
• Compiles data and prepare reports for completed C/Q activities including ETOPs, protocol data packages, etc.
• Execute Good Engineering practices for new equipment/Systems/utilities as applicable.
• Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Maintenance, Metrology, Engineering, EHS&S, and Quality Control to control assets throughout their lifecycles.
• Develop and execute cleaning/steaming cycle development. Procure new equipment, create and maintain the appropriate engineering records as required by appropriate agencies, including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering practices.
• Plan the execution of start-up and commissioning activities on equipment, utility and GMP manufacturing plant systems.
• Provide system expertise for troubleshooting system failures, deviations or unusual operations.
• Demonstrate an in-depth technical knowledge of (FSUE) systems to support the manufacturing, and warehousing of pharmaceutical, Medical device and biological products
• Effectively support internal and external relationships with customers, key stakeholders and vendors. Initiate, lead and execute Facilities cost improvement projects.
• Select and qualify vendors for the procurement of equipment and engineering systems.
• Develop process engineering controls and specifications for manufacturing processes and associated equipment.
• Develop and maintain effective communication with peers, subordinates and senior management. Demonstrate the ability to be self-directed with limited guidance and oversight from management.
• Effectively apply independent judgment utilizing policies, industry practices and standards as guidance.
• Demonstrate effective collaboration, partnering and teamwork skills when interacting with internal and external resources.
• Evaluate the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects to improve operational performance.

Requirements

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• A minimum of 8 years' experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry.
• Strong organization, interpersonal, oral and written communication skills.
• Experience with aseptic liquid filling of vials, aseptic lyophilization filling of vials, and aseptic processes, including refrigerated and frozen capabilities a Plus.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the EU and US FDA. Process control and Instrumentation for facility control systems experience is desired.
• Process control and instrumentation for facility control systems experience is desired.
• Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA systems.
• Proficiency with standard applications, including MS Word, MS Excel, MS Project, MS Power Point, MS Access.
• Extensive knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices. A vast amount of engineering/ technical experience in a manufacturing environment is preferred.
• Knowledge and practical experience in using world class manufacturing, lean manufacturing, continuous improvement and variation reduction techniques e.g. Six Sigma, DMAIC and FMEA tools.

For immediate consideration please email John Cuello, at