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)