Plant Engineer III

About the Role

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. This role 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 plant facilities, equipment, utilities, and systems. Engages with functional department leaders to establish an understanding of departmental needs and requirements from an equipment capability and capacity perspective. Ensures inclusion of existing site facility and engineering team members in the learning and design processes for new plant systems, including 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.

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.
• 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, commissioning, and 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 investigations, re-occurring problems, required modifications, optimizations, and continuous improvements.
• Work with end users to develop system requirements, specify equipment/buildings, support fabrication, and perform Factory/Site Acceptance Testing.
• Prepare URS, ETOPs, Risk Assessments, Safety Assessments, and other good engineering documents associated with FSUE as required.
• Execute good engineering practices for new equipment/systems/utilities as applicable.
• Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure PCI Pharma Services 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, create and maintain appropriate engineering records including equipment records and manuals, drawings and diagrams, and inspection reports per good engineering policies.
• Support the execution of start-up and commissioning activities on equipment, utility, and GMP manufacturing facilities, systems, utilities, and equipment.

Qualifications

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• A minimum of 5+ years’ experience in engineering, facilities clean utilities, and/or plant utilities, preferably in the 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, maintaining regulatory compliance.
• Experience with aseptic liquid filling of vials, CIP/SIP and clean rooms, lyophilization, aseptic filling of vials, and aseptic processes, including refrigerated and frozen capabilities (a plus).
• Experience with Computerized Maintenance 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 the application of 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.
• Ability to effectively support internal and external relationships, key stakeholders, and vendors.
• Excellent understanding of team and group dynamics.
• Demonstrated agility to work in a fast-paced CMO environment.
• Excellent technical writing abilities.