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Process Engineer

2 months ago


Carteret, New Jersey, United States The Spear Group Full time
Job Description

We are seeking a highly skilled Pharmaceutical Process Engineer to join our team at The Spear Group, Inc.

The ideal candidate will have a strong understanding of Good Manufacturing Practices (GMPs) and experience providing Project Engineering support End to End in highly regulated pharmaceutical facilities.

Key Responsibilities:

  • Function as the technical/engineering process/utility engineer on assigned projects with prior experience supporting Biologics, Vaccine and/or Sterile Projects.
  • Significant experience with engineering design, equipment operation, vendor interface, risk assessment, process safety and industry guidance are essential for delivery of assets and project realization.
  • Experience in designing, commissioning and qualifying critical utilities (WFI, Purified Water, Nitrogen, Clean Dry Air, Oxygen)
  • Understand the function of critical equipment (Chromatography Skids, Single Use Equipment Mixers, Inline dilution, Milling Equipment, Stainless Steel/Hastelloy Portable reactors, HTHM/Solvent dispensing, Temperature Control Modules)
  • Experience with equipment that utilize Tangential Flow filtration (TFF)
  • Support containment verification activities
  • Support and Leads project design efforts, providing innovative solutions that meet business objective.
  • Collaborates with cross-functional team in the evaluation of alternative solutions and the development of project scope.
  • Ensures that deliverables conform to company standards and practices, and are technically sound.
  • Liaises with other technical functions to ensure successful technology transfers of new and in-line products.
  • Apply enthusiasm and technical skills as a member of a multidisciplinary team
  • Challenge traditional practices to make way for innovative/creative solutions.
  • Support the manufacture of product engineering and validation lots.
  • Support technical investigations.
  • Challenge traditional practices to make way for innovative/creative solutions.
  • Support the manufacture of product engineering and validation lots.
  • Support regulatory submissions.
  • Drive process/business system improvements

What We Offer:

Competitive Salary offerings, Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, and an Equal Opportunity Employer environment.