Plant Engineer IV Job at PCI Pharma Services (Bedford)

Job Description

The Plant Engineer IV provides hands on 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. Drives equipment capabilities and capacity to realize the site’s growth trajectory. Supports and complies with engineering standards, drawing controls, project controls and other procedures and standards necessary for the successful operation of the department as well as the creation and maintenance of the same. Support / Implement process equipment projects’ life cycle; Design, Procurement, c-GMP documentation (URS, Design Specifications, FAT, SAT & Commissioning), Testing, Installations, Startups & Commissioning of cGMP Manufacturing systems delivering robust & compliant solutions. Behaves as a change agent to help drive innovation and operational effectiveness.

Job Responsibility

Provides hands on 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
Drives equipment capabilities and capacity to realize the site’s growth trajectory
Supports and complies with engineering standards, drawing controls, project controls and other procedures and standards
Support / Implement process equipment projects’ life cycle
Design, Procurement, c-GMP documentation (URS, Design Specifications, FAT, SAT & Commissioning), Testing, Installations, Startups & Commissioning of cGMP Manufacturing systems
Author user requirements for equipment, instrumentation, and other activities and create standard operating procedures
Provide technical training to appropriate personnel
Create/update Isometrics, P&IDs and PFDs, authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems
Lead major projects and tracking spending of budgets, creating scope of work, risk assessments, justification, cost estimates, implementing purchase order requisitions, contracts, funding requests, and controlling their payment
Establish and streamline/innovate 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 Technical input for Architectural features, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, Automation
Design and execution of engineering runs to test equipment or to troubleshoot problems
Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing
Support Manufacturing, Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities, and equipment
Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (FSUE) as required
Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control
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
Champion safety in design and operation of the facility and systems

Requirements

BS in Chemical, Mechanical, or other Engineering degree
Minimum of 7 -10 plus years of facilities design/development, facilities construction, and plant engineering/maintenance activities
Plant Engineering experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries)
Advanced understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles
Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system
Plant Engineering skills to successfully implement process equipment projects from design to Commissioning
Effective in managing internal and external relationships, key stakeholders, and vendors
Excellent understanding of team and group dynamics
Demonstrated agility for working in a fast-paced CMO environment, doing so independently with minimal supervision
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
Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices
Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point

Nice to have

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
Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices

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Plant Engineer IV

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