Lead Process Engineer

2 weeks ago

Salem, New Hampshire, United States InnoTech Staffing Full time
Job Overview

InnoTECH Staffing is in search of a Senior Process Engineer with over 5 years of experience in the design of biochemical systems. This position does not offer relocation or sponsorship at this time.

Position Summary

The ideal candidate will be responsible for the design, implementation, and optimization of biochemical and chemical systems. This role is crucial for ensuring the functionality and dependability of GMP manufacturing process equipment. The Senior Process Engineer will collaborate with Facilities, MS&T, and Equipment End Users to identify and resolve issues related to process equipment.

Key Responsibilities

  • Act as a Technical Lead for capital projects, managing GMP manufacturing process equipment.
  • Work closely with MS&T, Facilities, Validation, and equipment End Users to effectively drive projects to completion.
  • Ensure efficient and effective execution of projects to meet set objectives and timelines.
  • Provide direct engineering support and Subject Matter Expertise for various process equipment, including Ultrafiltration, Chromatography, Mixing Systems, and Fermenters.
  • Deliver results by managing medium to large-scale projects with complex subject matter and tight timelines.
  • Produce high-quality technical documentation within the required quality systems, ensuring project timelines are met to avoid production schedule disruptions.
  • Participate in all phases of engineering projects related to process equipment, from conceptual design to validation and qualification.
  • Troubleshoot equipment to identify root causes of failures, independently driving resolution and managing Corrective/Preventative Actions.
  • Maintain quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
  • Contribute to preventative maintenance plans and continuous improvement initiatives.
  • Manage Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.

Qualifications

  • Bachelor's degree in Chemical or Mechanical Engineering.
  • A minimum of 5 years of relevant experience as a Process Engineer.
  • Ability to utilize technical expertise to investigate issues using a structured problem-solving approach.
  • Proven capability to identify root causes and develop effective corrective and preventative actions for complex problems.
  • Strong interpersonal skills to collaborate effectively with various teams and take ownership of assignments.
  • Ability to manage multiple complex assignments simultaneously with minimal supervision.

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