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CSV Engineer

  1. North America, East Coast
Texas
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36375
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CSV Engineer  - Texas - 6- 12 Months contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented CSV Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Responsibilities: 
  • Generate, obtain approvals and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
  • 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
  • Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
  • Must be able to review all 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 create, review, and update SOPs, forms, templates, documentation and files.
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
Skills required: 
  • Working knowledge and expertise in computerized systems validation.
  • Computer System Validation experience with Data Integrity for Lab Equipment like Osmometers.  CSV experience with LabX preferred.
  • Familiarity with 21 CFR Part 11, Annex 11,  Data Integrity , GAMP5 and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
  • Ability to work with minimal supervision.
  • Bachelor of Science in an Engineering discipline
  • Extensive experience in computer system validation activities in pharmaceutical, biotechnology, or related industry , preferably in FDA-regulated environments.
  • cGMP experience.

Interested in this role? Apply today! 

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