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Lead Process Engineer

2 months ago

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

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

Role Summary

The ideal candidate will be responsible for the design, implementation, and optimization of biochemical and chemical systems. This position requires ensuring the functionality and dependability of GMP manufacturing process equipment. Collaboration with Facilities, MS&T, and Equipment End Users is essential for investigating and resolving 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 projects are executed efficiently to meet established objectives and timelines.
  • Provide direct engineering support and Subject Matter Expertise for various process equipment, including Ultrafiltration, Chromatography, Mixing Systems, and more.
  • Deliver results by managing medium to large-sized projects with complex subject matter and tight timelines.
  • Produce high-quality technical documentation within the required quality systems, ensuring project timelines are adhered to.
  • 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, 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.
  • Prepare 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 a structured problem-solving approach to investigate issues and develop effective corrective and preventative actions.
  • Proven capability to identify root causes and devise solutions for complex problems.
  • Strong interpersonal skills with the ability to take ownership of assignments and follow through effectively.
  • Proficient in managing multiple complex assignments simultaneously with minimal supervision.