Senior Process Engineer

4 weeks ago

Salem, United States InnoTech Staffing Full time
Job DescriptionJob Description

InnoTECH Staffing is looking to hire a Senior Process Engineer who has 5+ years experience designing biochemical systems.
This is no relocation or sponsorship offered at this time.

Summary

We are seeking a Senior Process Engineer that can design, implement and optimize biochemical and/or chemical systems.
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Responsible for ensuring the operability and reliability of GMP manufacturing process equipment. Will work closely with Facilities, MS&T, and Equipment End Users to investigate and troubleshoot issues related to process equipment.


Responsibilities

  • Serve as a Technical Lead for Capital projects, overseeing GMP manufacturing process equipment
  • Collaborate closely with MS&T, Facilities, Validation, and equipment End Users to successfully drive projects to completion
  • Ensure that projects are executed efficiently and effectively to meet objectives and timelines
  • Provide direct engineering support and Subject Matter Expertise for process equipment such as the following: (Ultrafiltration, Chromatography, Mixing Systems, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.)
  • Drive results by owning and completing medium to large-sized projects with challenging timelines and complex subject matter
  • Provide high-quality technical writing within the required quality systems and meet project timelines to ensure the production schedule is not impacted
  • Participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment
  • Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated Change Controls
  • Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required
  • Provide input into preventative maintenance plans, assessing Change Controls, and continuous improvement initiatives
  • Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment

Skills and Qualifications

  • A bachelor’s degree in Chemical or Mechanical Engineering
  • Minimum of 5 years relevant experience as a Process Engineer
  • Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine root cause and develop effective corrective and preventative actions
  • Must be able to be able to find root cause and path forward for complex problems
  • Ability to interact well with other groups and must be able to take ownership of and follow through on assignments
  • Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor

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