CSV/ CQV Engineer

Location: Philadelphia
Department: Azzur IT, LLC

Job Description

We at Azzur Group are looking for an CSV/CQV Validation Engineer to join our Azzur Consulting: Philadelphia team. 

  1. Function as the computer systems validation subject matter lead for specific CSV/CQV related projects that require quality assurance, and CSV/CQV regulatory / GxP expertise.
  2. Develop and/or provide input to all CSV/CQV related life cycle deliverables.
  3. Perform testing of the entire SDLC, including version/change control and new software rollouts.
  4. Provide guidance to CSV teams, including but not limited to: 21 CFR Part 11, risk-based approach to computer systems validation (e.g. GAMP5®), data integrity, and computer systems assurance.
  5. Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
  6. Ensure that the testing is sufficient to meet GxP regulatory requirements.
  7. Familiar with CSV of stand-alone, networked, and enterprise applications.
  8. Familiar with IT Infrastructure qualification, including control, compliance, and qualification of infrastructure components.
  9. Conducts audits related to computer systems: supplier audits, internal compliance audits, gap assessments and provides recommendations for corrective actions.
  10. Familiar with GxP Compliant laboratory computerized systems, and Good Engineering Practices as outlined by GAMP and standards American Society for Testing and Material (ASTM) E2500 and US Pharmacopeia General Chapter <1058>.

Requirements

  1. BS in Engineering, Science or equivalent technical degree.
  2. Minimum 7 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  3. Strong working knowledge of FDA and cGMP regulations and documentation practices.
  4. Proficient in Microsoft Word, Excel, PowerPoint.
  5. Excellent written and verbal communication skills; excellent technical writing skills.
  6. Strong interpersonal skills and the ability to work in a team environment.
  7. Ability to work effectively in a fast-paced multitasking environment.


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