Process Engineer

3 weeks ago

Rahway, United States The Spear Group Full time
Job DescriptionJob Description

Seeking a Pharmaceutical Process Engineer with minimum of 5-15 years experience.

Ideal candidates should have a strong understanding of GMPs and experience providing Project Engineering support End to End in highly regulated pharmaceutical facilities. Candidates should have demonstrated experience with manufacturing processes

  • Functions 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)
  • Understands 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

Salary: Competitive Salary offerings

Benefits: Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are effected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.

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