Process Engineer

4 weeks ago


Cambridge, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
  • Lead CAPA investigations and at times manage the implementation of CAPA.
  • Own manufacturing related change controls.
  • Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
  • Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
  • Review production documentation and perform quality walk-throughs during manufacturing events.
  • Participate in continuous improvement teams such as 5s, Gemba and the *** Production Systems (GPS).
  • Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
  • Lead team meetings and facilitate multidepartment discussions.
  • Stay current with biopharmaceutical industry best practices and technologies.
  • Other duties as assigned.
Requirements:
  • Bachelor's degree or equivalent experience.
  • 3+ years of related experience.
  • Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
  • Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
  • Good computer skills, knowledge of Microsoft office products - Word, Excel, Office.
  • Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
  • bility to meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.
  • bility to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.


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