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Senior Aseptic Filling Process Engineer

Senior Aseptic Filling Process Engineer
Woburn, MA
Employment Type
Full Time
Required qualifications
  • 8-10 years of engineering experience for a cGMP fill-finish pharmaceutical production setting.
  • Experience with the following unit operations as pertaining to the downstream process. These systems include API transport/storage, formulation, sterile filtration, vial filling, terminal sterilization, and automatic visual inspection. Experience with every unit operation is not required, but the ability to quickly understand and build a working knowledge of a new unit operation is a requirement.
  • Experience in the design of aseptic processing equipment and facilities with a strong understanding of sterilization concepts and methods is required.
  • Experience and strong understanding of cGMP facility requirements especially those related to producing sterile solutions (ISO room classifications, environmental monitoring, material / personnel flows, water-for-injection, high quality air systems, HVAC with HEPA filtration, mold identification and mitigation, clean-in-place, steam-in-place, etc.).
  • 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).
  • Experience in creating design documents, drafting user requirement specifications, technically evaluating bids, reviewing vendor equipment drawings/documentation packages, participating in FAT’s and SAT’s, etc.
  • Ability to carry out detailed engineering activities, including but not limited to the following:
  • Engaging in plant-wide risk assessments (e.g., PHA)
  • Preparation of process calculations
  • Drafting and review of BFDs, PFDs, P&IDs, layouts, etc.
  • Experience with developing and/or executing Commissioning, Equipment Qualification, and Performance Qualification documents.
  • Experienced in start-up of critical process utilities such as WFI.
  • Thorough understanding of Statistical Process Control & Process Capability CpK.
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