Fresenius Medical Care Job - 42536735 | CareerArc
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Company: Fresenius Medical Care
Location: Ogden, UT
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

M-F 8-5 (Days)

PURPOSE AND SCOPE:

Supports plant projects and software validations for new and existing equipment, develop, test and implement hardware/software technology and control equipment for the development or improvement of manufacturing processes. Responsible for providing quality support of special projects or process improvement projects.

 

 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Develops, tests and implements hardware/software of new technology to obtain manufacturing enhancement for process improvement.
  • Maintains good documentation practices for all protocols, reports, validations and in all areas of responsibility.
  • Establishes and/or revises validation protocols, SVD's, SOP's, drawings, equipment specifications, Engineering Test Reports (ETR) and technical reports.
  • Writes project proposals, equipment specifications, operating procedures and test methods.
  • Performs testing and evaluation of process validations, and software validations in compliance with all Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualification (PQ), software development and product design.
  • Remains current with knowledge related to process validation techniques by continuous assessment of current publications, standards and regulations.
  • Performs corrective and preventativeactions.
  • Assists in training of production and maintenance staff on new equipment and software applications or improvements.
  • Assist departmental staff in troubleshooting process problems.
  • Maintains compliance with all state and federal regulations, SOPs and company policies.
  • Maintains general housekeeping of working area and plant.
  • Self-motivated to improve knowledge related to process and validation techniques by continuous assessment of current publications standards and regulations.
  • Designs flow diagrams, updates schematics, processes drawings, and provides recommendations as support of improvements to manufacturing processes.
  • Provides technical support and assistance to junior level staff that require a better understanding of functions and by responding to support requests regardingerrors, problems, or assistance as directed by immediate supervisor/manager. Builds productive working relationships.
  • Orders equipment and supplies related to projects.
  • Maintains inventory of software required in operating computers for Human Machine Interface (HMI) and PLC's. Responsible to load and update software applications as required.
  • Assists in training of production and maintenance personnel on new equipment and software applications or improvements.
  • Maintain compliance with all GMP standards, ISO Standards, localStandard Operating Procedures (SOP)'s and company policies. Maintain a safe work environment for self and other employees.
  • May refer to senior staff,if applicable, for assistance with higher level problems that may arise.
  • Escalates issues to supervisor/manager for resolution, as deemednecessary.
  • Assist with various projects as assigned by direct supervisor/manager.
  • Other duties as assigned.

 

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

 

 

PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Regularly required to talk or hear, stand and walk.
  • Frequently required to sit; use hands and fingers to handle, reach with hands and arms; and wear protective equipment that may include steel-toed shoes, safety glasses, lab coat, etc.
  • Occasionally required to climb or balance, stoop, kneel, crouch, or crawl.
  • Ability to lift and/or move up to 50lbs.
  • Frequently exposed to moving mechanical parts and wet and/or humid conditions.
  • Occasionally exposed to fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; risk of radiation and vibration.
  • The noise level in the work environment is usually moderate.

EDUCATION:

  • Bachelor's Degree required

 

EXPERIENCE AND REQUIRED SKILLS:

  • 2 - 5 years' related experience; or an advanced degree without experience; or equivalent directly related work experience.
  • Skilled in logic controller programming, Human Machine Interface programming, Servo programming, Robotic programming is required or higher levels of code.
  • Must be able to prepare clear and informative engineering and technical reports with accuracy.
  • Expertise in electrical, electronic, pneumatic, heating/cooling systems, mechanical operations, and pressurized systems.
  • Ability to work with mathematical concepts such as probability, statistical inference, and fundamentals of plain and solid geometry and trigonometry at an engineering or scientific level.
  • Strong oral and written communication skills.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions. Apply principles of logical or scientific thinking to a wide range of situations.
  • Strong computer skills.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

 

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

 

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.


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