CSV Engineer Consultant
Description
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!
Essential Duties and Responsibilities
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.
- 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’ experience in a regulated environment within the biotechnology, pharmaceutical or medical device industry.
- Must have LIMS Experience, Environmental Monitoring
- 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. Ability to travel up to 50%
- Facility or Lab experience preferred
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