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Katalyst HealthCares & Life Sciences
Process/Validation EngineerKatalyst HealthCares & Life Sciences • Branchburg, NJ
Process/Validation Engineer

Process/Validation Engineer

Katalyst HealthCares & Life Sciences • Branchburg, NJ
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • Process and Cleaning Validation Experience.
  • Equipment Qualification (IOQ/PQ).
  • Quality System Experience (Veeva, Track wise, Compliance Wire).
  • Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with - Years.
  • Statistical Analysis (Minitab or JUMP).
  • The Process/Validation Engineer is responsible for providing engineering production support including:
  • Implementing process and technology improvements.
  • Process and Cleaning Validation.
  • Equipment Qualification.
  • Collecting, monitoring, analysing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market.
  • Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions.
  • Responsible for the initiation and follow-through of the change control processes.
Requirements:
  • Bachelor's degree in engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired - years of significant process engineering and/or operational experience in Medical Device or Pharmaceutical industry. Additional post-graduate education may contribute towards the desired years of experience.
  • Experience with MS Office applications including Word, Excel & Outlook.
  • Demonstrated understanding and use of statistical methods in experiment design and data analysis.
  • Able to work independently and proactively in conjunction with all levels of the organization.
  • Excellent Technical writing skills and attention to fine detail.
  • Understanding of AATB, FDA, ISO, ISPE, and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA CFR , and , ISO , and , and others, as required.
  • Six Sigma, Value Stream Mapping, Lean Manufacturing, Design for Manufacturability, DOE.
  • Biological Products and aseptic processes.
  • Development of robust manufacturing processes, validation, and process monitoring.
  • Experience with root cause analysis methods.
  • Experience with applications including Minitab or other statistical software, Client PowerPoint, Project, and Visio.
  • Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines.
  • Strategic thinking and planning.
  • Excellent organizational skills.
  • Excellent oral and written communication skills.

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Process/Validation Engineer • Branchburg, NJ

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