Process Engineering Specialist

Fresenius Kabi USA•Wilson, NC

10d•Onsite

About The Position

The Process Engineering Specialist assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs. The Process Engineering Specialist will assist in the installation of new equipment, equipment / process upgrades and troubleshooting existing equipment / processes to enhance plant operations. This role participates in developments and improvements to validated systems and equipment as needed to remain current with cGMPs and industry standards.

Requirements

solving problems
improving processes
reducing costs
installation of new equipment
equipment / process upgrades
troubleshooting existing equipment / processes
enhance plant operations
developments and improvements to validated systems and equipment
remain current with cGMPs and industry standards
preparing funding requests
detailed project descriptions
financial data
justifications and quotations
interact with vendors
discussions with all levels of the organization
integration of purchased equipment
acceptance, installation, and validation
process instructions for projects
new manufacturing equipment
upgrades to existing equipment
writing risk assessments
change controls for projects
setting up spare parts
fundamental operation of equipment
functionality training
analyzes production and processing problems
proposes ideas to correct them
implementation or leading of process improvement initiatives
evaluates results
interfaces with support and production functions
ensure availability of equipment for continuous improvement of the process

Responsibilities

Accountable for individual project management including preparing funding requests, with detailed project descriptions, financial data, justifications and quotations.
Must be able to interact with vendors and have discussions with all levels of the organization as it pertains to projects.
Supports the integration of purchased equipment during acceptance, installation, and validation.
Develops process instructions for projects involving new manufacturing equipment and upgrades to existing equipment. (i.e. SOP’s, Work Instruction)
Responsible for writing risk assessments and change controls for projects.
Responsible for setting up spare parts needed for new installations and process upgrades to current equipment.
Assist with fundamental operation of equipment and functionality training, as appropriate.
Analyzes production and processing problems and proposes ideas to correct them.
Support implementation or leading of process improvement initiatives and evaluates results.
Interfaces with support and production functions to ensure availability of equipment for continuous improvement of the process.