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Computer System Validation (CSV) Engineer

  1. North America, United States
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
35988
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Computer System Validation (CSV) Engineer - Pharmaceuticals  - 12-Month Contract 

This is a fantastic opportunity for a Computer System Validation (CSV) Engineer to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.

Job Responsibilities:
  • Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP), Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems
  • Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program
  • Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
  • Ensure that the Computer System Validation on the project is conducted in a consistently high standard, within budget, and that objectives are met on time suiting the company's vision and objectives
  • Collaborate and align with other Diosynth Biotechnologies sites
  • Coordinate with Computer System vendors as needed
  • Opportunities to make periodic International and Domestic travel Requirements
We are looking for a candidate with the following background and skill sets:
  • Bachelor’s degree in Chemical Engineering, Computer Engineering, Computer Science, Biological Science, or technical equivalent
  • Extensive direct Computer System Validation experience in a cGMP Pharmaceutical facility working with FDA regulations
  • Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including ASTM2500, GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
  • Working knowledge of Kneat validation software is a plus
  • Excellent oral and written communications skills and fluency in English
  • Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
  • Knowledge with Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing (FGM) would be beneficial
If this role is of interest to you, please apply now! 


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