Process Engineering Specialist

Fresenius

$70K — $95K *
Manufacturing & Automotive
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in process engineering or related field
  • Strong understanding of cGMP and industry standards
  • Proficient in project management and financial analysis
  • Excellent communication skills for vendor and organizational interaction
  • Experience in equipment installation and process validation
  • Knowledge of developing SOPs and work instructions

Responsibilities

  • Manage projects from funding request to project completion
  • Engage with vendors and internal teams for effective project execution
  • Support acceptance, installation, and validation of new equipment
  • Create process instructions for new and upgraded equipment
  • Write risk assessments and manage change controls for projects
  • Set up spare parts inventory for new installations
  • Analyze production issues and propose corrective actions
  • Lead or support process improvement initiatives and assess their success
  • Collaborate with support and production functions for equipment optimization

Benefits

  • Medical, dental, and vision coverage
  • Life insurance and disability benefits
  • 401K with company contributions
  • Wellness program
Full Job Description
Job Summary

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.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
  • 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.


Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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