CSV DI Engineer

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

• Review and revise system documentation (e.g., user manuals, SOPs, validation reports). including change controls for document changes
• Conduct system audits and inspections
• Analyze audit trails for evidence of data manipulation, deletions, or unauthorized access
• Review data for completeness, accuracy, and consistency
• Assess data backup and recovery procedures
• Periodic reviews of systems and equipment.
• Evaluate user access controls and permissions
• Compare current practices with data integrity requirements
• Identify gaps and deficiencies
• Prioritize identified gaps based on risk
• The contract staff will document the assessment process, including findings, recommendations
• Perform remediation activities for identified gaps as required by client project sponsor
• Maintain current knowledge of federal and international data integrity regulations
• Manage and prioritize project in an organized and structured manner
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EP, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
  
  
  

Requirements

• BS in Engineering, Science or equivalent technical degree
• 5 years' experience in a regulated environment within the biotechnology, pharmaceutical or medical device industry.
• Must have 3 years data integrity and computer systems validation experience
• Excellent written and verbal communication skills; excellent technical writing skills
• Strong interpersonal skills and the ability to work in a team environment
• Ability to work effectively in a fast paced multitasking environment
• Strong working knowledge of FDA and cGMP regulations and documentation practices
• Working for multiple clients through out the region
• Facility or Lab experience preferred
  
  
  

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)