Project Engineer

Project Engineer

24 Apr 2024
Pennsylvania, Swiftwater, 18370 Swiftwater USA

Project Engineer

Vacancy expired!

Candidates must be able to come onto our W2, no third parties. We are unable to sponsor H1B nor OPTSTEM candidates at this time.
This role will be supporting bacterial CI personnel for multiple projects on the Swiftwater site. Some work will be remote, but significant onsite presence will be required during executions.
The selected applicant will design, develop, approve and execute complex validation activities for pharmaceutical equipment and processes- to including "GMP on-location" execution, datapack compilation, data analysis, deviation resolution and report generation. In addition will:

  • include the design, development and approval of new or modified validation processes by coordinating agreement between stakeholders.
  • Coordinate with internal resources to ensure appropriate project tracking and change control execution.
Skills:
  • Experience in temperature mapping would be ideal.
  • Experience with fermenters, bioreactors and the deltaV control system would be a plus.
  • Complex Technical Writing within a cGMP environment.
  • Experience developing specifications, executing design reviews, performing criticality assessments, developing test scripts, executing common pharmaceutical tests, analyzing complex data packages and authoring complex technical reports preferred.
  • Experience developing and implementing novel processes and/or procedures in a cGMP environment preferred
  • Bachelor's Degree/Undergraduate Degree in chemical or mechanical engineering, or related degree supplemented with relevant experience.
  • Experience in pharmaceutical/biopharmaceutical industry.
  • Experience with relevant quality standards, including commissioning, qualification and validation.
  • Would prefer demonstrated experience managing teams consisting of internal staff, supervising engineering and construction activities, and preparing turnover documentation from execution and as-built drawings.
  • Demonstrated project controls skills such as estimating, scheduling and cost reporting.
  • Larger projects may require earned value/progress tracking systems.
  • Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.)
  • Years of Experience: 3 - 6 Years

Job Details

  • ID
    JC12566978
  • State
  • City
  • Job type
    Contract
  • Salary
    $35 - $40
  • Hiring Company
    Strategic Software Solutions, Inc.
  • Date
    2021-04-09
  • Deadline
    2021-06-08
  • Category

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