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Aspetic Process Engineer

DPS Group is looking for an Aseptic Process Engineer to work with a BioPharma client of ours in the Raleigh-Durham area. Ideally, you have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/ biotech facilities.

Category:
Engineer Process / Food / Dairy Science
Location:
North Carolina
Years of Experience Req.:
5+
Date Posted:
01/07/2019
Days Remaining:
48
Employment Type:
Full-time
Education Level Req.:
Bachelors


 

Your Responsibilities:

  • Process engineering for the startup of a new Aseptic/TS formulation and filling operation for vials and ampuls
  • Main equipment includes commodity washers, depyrogenation tunnels, fillers, Isolator/RABS, CIP skids, CIP/SIP processing, parts washers, formulation tanks/transfer systems, temperature control units and autoclaves
  • Working with existing project team to perform cycle development work under Engineering Studies
  • Understanding of the technical process to establish system matrixes for products and commodities, protocol development, execution of testing to define process parameters/capability to include recipe development and CPP/KPP identification
  •  Staying compliant to site procedures using cGMP and good documentation practices
  • Establishing methods for performance testing/sample collection


Your Qualifications:

  • BS/MS in Mechanical or Chemical Engineering, or related field/experience
  • 5+ years’ of experience working within a GMP or highly regulated engineering environment
  • Ability to work independently or part of a team on projects with applicable client stakeholders in Validation, Quality Assurance, Manufacturing, Maintenance, and other relevant personnel
  • Strongly motivated, well-organiz339942.480057ed, and show professional initiative
  • Abile to work in a fast-paced and challenging environment
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