PCI Pharma Services ยท 12 hours ago
Plant Engineer IV
Bedford, NH
Full-time
Onsite
Senior Level
7+ years expPCI Pharma Services is a company focused on delivering life-changing therapies with a global impact. The Plant Engineer IV role involves providing hands-on support in manufacturing facilities, focusing on process equipment improvements and compliance with engineering standards to enhance operational effectiveness.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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
Qualification
Required
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
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. 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
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
Preferred
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 working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase