Plant Engineer IV

PCI Pharma Services•Bedford, NH

About The Position

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. Summary of Objective: 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.

Requirements

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.
Excellent communication skills both verbal and written.
Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point.
BS in Chemical, Mechanical, or other Engineering degree and a 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
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.
Role model to set the tone for a highly collaborative culture.
Demonstrated agility for working in a fast-paced CMO environment, doing so independently with minimal supervision.
Interacts with all departmental staff.
Works closely with Engineering, Manufacturing, MTS, Quality, EH&S, Facilities, and Validation

Nice To Haves

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

Responsibilities

Author user requirements for equipment, instrumentation, and other activities and create standard operating procedures in alignment with broader operational strategies.
Provide technical training to appropriate personnel including but not limited to Plant Engineers, Facility Technicians, Operations personnel, and Validation 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 to ensure that PCI assets are well engineered and maintained throughout their lifecycles.
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.