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Senior Process Engineer (Downstream Processing)

Job
Senior Process Engineer (Downstream Processing)
Location
Woburn, MA
Employment Type
Full Time
Starting
ASAP
Required qualifications
  • 8-10 years of process engineering experience in a cGMP fill finish pharmaceutical production setting.
  • Experience with the following unit operations as pertaining to the downstream process. These systems include formulation, sterile filtration, vial filling, and terminal sterilization.
  • Experience in the design of aseptic processing equipment and facilities.
  • Experience and strong understanding of cGMP facility requirements especially those related to producing sterile solutions.
  • Excellent understanding of fundamental engineering principles and the engineering life cycle related to process design through implementation (e.g., installation, validation, change control, and process improvement).
  • Ability to lead designs from the concept stage through implementation
  • Extensive experience in the pharmaceutical field
  • Ability to determine deliverables, define requirements, create design documents and develop user requirement specifications.
  • Ability to carry out detailed engineering activities such as engaging in plant-wide risk assessments (e.g., PHA), preparation of process calculations, drafting and review of PFDs, P&IDs, layouts, etc.
  • Experience with developing and/or executing Commissioning, Equipment Qualification, and Performance Qualification documents.
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