Computer System Validation (CSV) Engineer III-IV / Veeva Platform Administrator - REMOTE

Essential Duties and Responsibilities

Azzur personnel are expected to always live up to our core values 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.

• Perform System Administrator duties for Veeva Quality Vault, including Quality Docs and QMS administration.

• Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
• Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
• Perform testing of the entire SDLC, including version/change control and new software rollouts.
• Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
• Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis,
• Design, Development, Testing and Deployment of Software Applications.
• Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).

Qualifications:

• BS in Engineering, Science, or equivalent technical degree.
• 5 years’ CSV experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or
• medical device industry.
• 2 years’ experience in Veeva Platform Administration
• Experience in the administration of Veeva Quality Vault including Quality Docs and QMS:
• Must be able to develop and update document and record workflows
• Must be able to develop custom objects and workflows including field creation, modification, and develop deployment/migration strategies between different environments.
• Must be able to perform Release Impact Assessments for platform releases
• Strong working knowledge of FDA and cGMP regulations and documentation practices including 21 CFR Part 11 and EudraLex Annex 11.
• Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
• 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.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Working for multiple clients throughout the region.

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers, and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

 Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

• Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
• Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
• Willing to work hands on, assist with building client libraries, learn from a mentor, and become a mentor for others.
• Understands worldwide regulations and phase appropriate applications
• Draws insights from projects and supplemental research to help drive new and existing growth.
• Ensures activities are efficient, optimized, and client centric.
• Highly motivated and organized, solutions-oriented leader
• Curious and adaptable - can transform knowledge into actionable activities
• Able to produce results in a fast paced, collaborative environment
• BS in Engineering, Science, or equivalent technical degree.