Plant Engineer III

pciservices; Bedford (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

PCI Pharma Services in New Hampshire is seeking a Plant Engineer III to provide engineering support across manufacturing facilities, leading equipment improvements, capital projects, and start-up for new plant systems. You will collaborate with cross-functional teams, ensure cGMP compliance, and drive safety, reliability, and continuous improvement of utilities and processes including water pretreatment, steam, HVAC, and lyophilization.

Experience in aseptic filling and clean room is a plus.

Qualifications

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• 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
• GMP and non-GMP change control, maintaining regulatory compliance
• 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 with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system.

Responsibilities

• Support safety through personal engagement and promote individual accountability for safety within the Plant Engineering Department.
• Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning; coordinating fabrication, procurement, installation, engineering start-up, and validation activities including IQ/OQ protocols.
• Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects from initial concept to final closeout.
• Design and execution of engineering runs to test equipment or troubleshoot problems.
• Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment.
• Identifies and resolves problems in a timely manner; develops alternative solutions; works well in group problem solving situations.
• Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other engineering documents for Facilities, Systems, Utilities and Equipment (FSUE).
• Execute good Engineering practices for new equipment/Systems/utilities as applicable.

Skills

Technical project management

Good Engineering Practices

Lean Principles

GMP/Change control

Aseptic filling / lyophilization

CMMS

AutoCAD

SolidWorks

PLC & SCADA

Education

BS in Chemical or Mechanical Engineering

Tools

AutoCAD

SolidWorks

PLC & SCADA

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Description

Summary of Objective

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.

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. Conduct all activities in accordance with cGMP, EH&S, and the site quality systems.
• Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning & qualification Coordinating 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 engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout.
• Design and execution of engineering runs to test equipment or to troubleshoot problems. Design and execution of engineering runs to test equipment or to troubleshoot problems
• Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment
• Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; Develops alternative solutions; works well in group problem solving situations.
• provides the technical support for the user with respect to investigations, re-occurring problems, required modifications, optimizations and Continuous Improvements.
• Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing.
• Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (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 that 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 Facilities, Systems, Utilities and Equipment (FSUE).
• Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, 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 plus 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
• GMP and non-GMP change control, maintaining regulatory compliance
• 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 with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system.
• Experience wo