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Senior Validation Engineer

4 months ago

Austin, United States Azzur Group Full time
Summary:The Validation Engineer III will be responsible for drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.

Essential Functions:
  • Generate, obtain approvals, and execute validation deliverables for FUSE systems and relevant infrastructure, including Validation Plans, System Impact Assessments, User Requirements Specification, Risk Assessments, Installation/Operational Qualifications and Performance Qualifications (as applicable) and Validation Final Reports, ensuring documents meet regulatory and procedural requirements.
  • Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
  • Must be able to review all FUSE System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
  • Must be able to review, and update SOPs, forms, templates, documentation, and files.
Required Skills & Abilities:
  • Significant working knowledge of engineering principles.
  • Strong working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.
  • Efficient Knowledge ISPE Baseline 5, Vol. 2 - Commissioning and Qualification and FDA industry regulations.
  • Solid written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
  • Ability to work with general guidance from Sr. Validation Engineers-Specialists /Validation Manager.
  • Able to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
Qualifications:
  • Masters Degree with two (2) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Bachelors Degree with four (4) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Associates Degree with six (6) years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Preferred Qualifications:
  • Degree in Engineering or Science Discipline.


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