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Validation

Townsend & Associates Swiftwater Contractor
Competitive salary based on experience
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Validation

Responsibilities:
  • Support development / validation activities
  • Generate development / validation protocols and reports.
  • Compile data packs and analyze data for adherence to established acceptance criteria.
  • Typical processes being developed / validated include mixing, filling, filtration and shipping. Studies supporting these processes include hold time, CCIT, stability and extractables / leachables.
  
Validation
Validation

W2 ONLY!!! NO CORP TO CORP!!!


Qualifications:
  • BS/MS in Engineering, Life Science or Physical Science.
  • Proficient in E Doc with a working knowledge of templates, workflows and approval process.
  • MS Office 2010 required.
  • Proficient in MS Word, Excel, PowerPoint and Outlook.
  • Formulation process validation experience required.
  • Filling process validation experience required.
  • Aseptic Processing experience required.
  • Hands on experience executing process validations required.
  • CPP required.
  • Strong root cause analysis skills with cGMP experience.
  • Significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling equipment sufficient to identify process CPP's and generate detailed validation protocol requirements and execution for filling.
  • Demonstrated experience with mixing and filtration process validation for formulation.
  • Pharmaceutical Validation skills.
  • Bio Pharma Validation skills.
  • Validation execution skills.

Validation

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Job ID: 17-02106

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