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Single-Use Technology/Disposables Project Engineer (SUT) JD815723

JD815723

DPS Engineering is looking for an accomplished Project/Process Engineer with specific experience around single-use/disposable technology to work with a BioPharma client of ours in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/ biotech facilities.

Category:
Engineer Chemical
Location:
Massachusetts
Years of Experience Req.:
3+
Date Posted:
15/02/2019
Days Remaining:
12
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Single-Use Technology / Disposables Project Engineer (SUT)    JD815723

Boston, MA

 

Summary:

 

DPS is looking for an accomplished Project/Process Engineer with specific experience around single-use/disposable technology to work with a BioPharma client of ours in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and experience providing engineering support in highly regulated or pharmaceutical/ biotech facilities.

 

Core Responsibilities:

  • This individual will complete a gap analysis between the required manufacturing needs and ensure alignment of these needs with the User Requirements Specification. 
  • Review data and technical specifications for each Single-Use Technology (SUT) that is available either from the vendor or through other means to ensure the component is suitable for its intended function as needed by the client.
  • Manage the SUT vendors, engineering, materials manufacturing throughout introduction of replacement or new SUT equipment.
  • Experience in review of P&IDs, PFD and assembly of SUT for best use is preferred.
  • Document the design review of Single-Use (SUT) components and sub-component materials of construction for use within client’s GMP manufacturing processes.
  • Remediate any discrepancies for any single-use technology or component in the event that the SUT specification does not meet the manufacturing specifications. 

 

Qualifications:

  • Bachelor’s Degree in Science or Engineering or a related field or 2+ years equivalent experience
  • Experience with upstream and downstream biopharmaceutical facility design.
  • Knowledge of Good Engineering Practices (GEP) and familiarity with ASME BPE, ASTM E2500 methodology is preferred.
  • Comfortable in technical interface between Manufacturing, Quality, and Engineering SMEs and Vendors during completion of assessments.
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