Lab CSV Engineer

The Lab Systems CSV Engineer will be responsible for the execution of Laboratory Computer System Validation activities within the AIQ framework. (Analytical Instrument Qualification)

The successful candidate will be part of the Lab Services Team which will deliver validation elements for lab systems.

Individual is expected to be self-motivated and develop an understanding of the business.

Experience of working in a pharmaceutical manufacturing operation or a regulated environment is desirable.

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• Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
  
• End to End ownership of Change Controls and their results.
  
• Author\Review\Approve qualification documents for lab systems.
  
• Work with site teams on generation of requirements and\or configuration of specifications and IOQ test protocols.
  
• Execution of IOQ protocols for lab analytical instruments.
  
• Generation of risk assessments.
  
• Be a key SME for the AIQ process for all GMP audits.
  

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• Minimum 3 years experience supporting and validating lab equipment, updating documentation, system testing, and troubleshooting.
  
• Knowledge of 21CFR Part 11 requirements and data integrity guidelines is desirable.
  
• Strong oral and written communication skills with proven ability to communicate and build relationships cross-functionally.
  
• Self-motivated, detail-oriented, with excellent organizational and time management skills.
  
• Capable of relating well to other people with whom s/he comes in contact both within and outside of the laboratory area. xcfaprz
  
• Manage lab equipment validation projects from software install to business release.