Job Posting for Process Validation at Katalyst HealthCares & Life Sciences
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.
Any 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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