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Process Validation

2 months ago

South Boston, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Client is looking for a Senior Process Validation consultant who has some TMV experience.
  • They are good on the process engineering side and the consultant will be responsible for writing/executing process validation protocols.
  • Wants to see a strong documentation and writing background, core of the job.
  • Will run some PQs and challenges on the process.
  • The protocols are very large and detailed and are a cornerstone for the company.
  • Must be strong at setting up protocols.
  • Will be a team of 3-4 people, working through 5-6 protocols for product family.
  • Group works on animal tissues that is chemically soaked, lyophilized and then backend testing.
  • Very complex process validations and the process is highly manual.
  • Will manage 2 protocols and the associated documentation.
  • There could also be some TMV work assigned, including moisture content analyzer, Instron, burst and help with procedures for setting up test methods with Micro.
Requirements:
  • Must have a strong Process Validation background and excellent documentation/writing skills.
  • Experience with protocol writing and execution.
  • Must have a core Medical Device background but is fine with some Pharma.
  • Very hands on position and the manager needs someone who can work in the trenches.
  • Need to be flexible, adapt and pick things up quickly.
  • ny Tissue experience is a plus. BS in scientific area preferred.
  • Required Skills: Process Validation, Protocols, Documentation, Medical Device, TMV (some exposure).

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