Pharmaceutical Process Engineer

2 days ago


Rahway, 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.

The successful candidate will have demonstrated experience with manufacturing processes, including:

  • Functioning 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)
  • Understanding 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)
  • Supporting containment verification activities
  • Supporting and leading project design efforts, providing innovative solutions that meet business objectives.
  • Collaborating with cross-functional teams in the evaluation of alternative solutions and the development of project scope.
  • Ensuring that deliverables conform to company standards and practices, and are technically sound.
  • Liaising with other technical functions to ensure successful technology transfers of new and in-line products.
  • Applying enthusiasm and technical skills as a member of a multidisciplinary team
  • Challenging traditional practices to make way for innovative/creative solutions.
  • Supporting the manufacture of product engineering and validation lots.
  • Supporting technical investigations.
  • Supporting regulatory submissions.
  • Driving process/business system improvements

What We Offer:

Competitive Salary offerings, Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, and a commitment to fostering an environment that respects the dignity, rights and contributions of our employees.

The Spear Group, Inc. is an Equal Opportunity Employer and is dedicated to upholding federal, state, and local civil rights laws and working to ensure that all of our personnel actions and policies are in compliance.


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