Project Engineer

Company: ACL Digital
Location: Swiftwater
Posted on: February 24, 2021

Job Description:

Project Engineer II (Engineering)Swiftwater, PA12 Months contract to begin.

• 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, data pack compilation, data analysis, deviation resolution and report generation.
• This role will additionally 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.
• Other duties as assigned. 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 Client 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.
  • Well-develop.
  • Well-developed communication skills, both verbal and written.
  • Based on level, should have demonstrated experience managing teams consisting of internal staff, supervising engineering and construction activities, and preparing turnover documentation from execution and as-built drawings.
  • Based on level, demonstrated project controls skills such as estimating, scheduling and cost reporting. Larger projects may require earned value/progress tracking systems. Leadership skills.
  • Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.)..
  • Years of Experience: 3 - 6 Years

Keywords: ACL Digital, Scranton , Project Engineer, Engineering , Swiftwater, Pennsylvania