Sr. Principal Engineer

Fresenius Kabi•Wilson, NC

21h

About The Position

Leads the design, development, implementation and support of all aspects of automation, electrical control systems, equipment, and machinery related to site utilities, production equipment, and facilities. Is a technical leader and subject matter expert within Engineering, and a resource to the Maintenance and Validation departments to meet all regulatory and company specific policy requirements and to improve plant efficiency, capacity, and capability via continuous improvement and modernization objectives.

Requirements

Technical leader and subject matter expert within Engineering
Resource to the Maintenance and Validation departments
Meet all regulatory and company specific policy requirements
Improve plant efficiency, capacity, and capability via continuous improvement and modernization objectives
Experience with automated packaging and associated Programmable Logic Controllers (PLC), Human-Machine-Interfaces (HMI), and server/industrial IT network infrastructure
Experience implementing and maintaining complex production and packaging systems in a compliant (cGMP/data integrity) validated and operational state including calibration, maintenance, repairs, and hardware/software updates
Experience with capital improvement projects, including: funding requests, acquisition, installation, startup and associated documentation (including Risk Assessments, User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures)
Experience rebuilding and upgrading of site utility systems and production equipment associated with packaging, and warehousing/distribution areas
Ensuring the validated state of all equipment, systems and facilities and compliance with all applicable cGMP (including data integrity), OSHA, DEC, EPA, ISO and local government regulations
Developing relationships with key vendors for technical support and for assistance in hardware applications
Works without supervision on highly complex projects with extensive latitude for independent judgement
May supervise 3-5 direct reports
Acts as advisor to the engineering team, project teams, and plant management to meet schedules and budgets and/or resolve complex technical issues
May manage the work efforts of supervisors

Nice To Haves

Experience with multiple disciplines and technical principles

Responsibilities

Responsible for the research, development, design, layout, building, testing, troubleshooting, repairs and improvement of all manufacturing equipment.
Responsible for the development, implementation, and technical support/ for all automated packaging and associated Programmable Logic Controllers (PLC), Human-Machine-Interfaces (HMI), and server/industrial IT network infrastructure.
Responsible for implementing and maintaining complex production and packaging systems in a compliant (cGMP/data integrity) validated and operational state including calibration, maintenance, repairs, and hardware/software updates.
Guides the conceptualization and development of new methodologies, processes, materials, machines, and computerized equipment for a pharmaceutical production environment.
Generates innovative solutions to complex problems through the use of multiple disciplines and technical principles and advises senior management regarding appropriate action.
Responsible for developing and implementing improvements for efficiency, safety and preventing equipment obsolescence.
Leads capital improvement projects, including: funding requests, acquisition, installation, startup and associated documentation (including Risk Assessments, User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures), and other items deemed appropriate by management.
Responsible for rebuilding and upgrading of site utility systems and production equipment associated with packaging, and warehousing/distribution areas.
Responsible for ensuring the validated state of all equipment, systems and facilities and compliance with all applicable cGMP (including data integrity), OSHA, DEC, EPA, ISO and local government regulations.
Responsible for developing relationships with key vendors for technical support and for assistance in hardware applications.
Networks with key contacts outside own area of expertise.
Works without supervision on highly complex projects with extensive latitude for independent judgement.
May supervise 3-5 direct reports.
Acts as advisor to the engineering team, project teams, and plant management to meet schedules and budgets and/or resolve complex technical issues.
May manage the work efforts of supervisors