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Engineering Knowledge Management

Job
Engineering Knowledge Management
Location
Woburn, MA
Employment Type
Full Time
Starting
ASAP
Required qualifications
  • 3-5 years of similar experience in a cGMP pharmaceutical production setting.
  • Broad understanding of the different process and utility equipment used in the pharmaceutical processing Industry.
  • Experience drafting user requirement specifications, functional specifications, data sheets, requests for proposal, and other design documents.
  • Ability to review and understand engineering drawings (e.g., BFDs, PFDs, P&IDs, electrical diagrams, plant layouts, GAs, etc.)
  • Experience with compiling and reviewing engineering turn over packages.
  • Experience with drafting vendor scopes and compiling vendor documentation requirements as related to the pharmaceutical Industry.
  • Experience preparing for FDA audits.
  • AutoCAD experience.
  • Thorough experience with 21CFR guidance documents.
  • Experience with Computerized Maintenance management systems.
  • Strong knowledge of Microsoft Office (Word, Excel, Power Point, Teams).
  • High attention to detail and accuracy.
  • Possess basic filing & indexing skills and comfortable in the use of printing and scanning.
  • Proven ability to work independently and flexibility to shift priorities in urgent situations.
  • Proven ability to quickly learn and understand complex topics.
  • Superior written and verbal communication skills, with a keen eye for detail.
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