IT Validation Analyst/Engineer Job

IT VALIDATION ANALYST/ENGINEER needed for a CONTRACT opportunity with Yoh's client located in Woodcliff Lake, NJ.

WHAT YOU'LL BE DOING:

- Organize, coordinate and gather requirements to perform integration/regression tests
- Formulate and compose user training materials, procedure manuals for implemented systems
- Conducting vendor audits and preparing audit reports
- Performing assessment activities to formulate validation plans and 21 CFR Part 11 compliance plans
- Executing validation plans and performing project management activities
- Developing and writing SOP's
- Developing test scripts and user acceptance tests and executing test scripts
- Performing IQ/OQ activities
- Preparing all validation/21 CFR Part 11 reports, documents, and deliverables
- Conducting validation and 21 CFR Part 11 training
- Contributing to the development of validation methodology and 21 CFR Part 11 compliance strategies

WHAT YOU NEED TO BRING TO THE TABLE:

- Seven (7) plus years Pharmaceutical or CRO industry experience with clinical/safety systems
- 10 plus years of experience developing and implementing the validation process and validation deliverables
- Excellent understanding and experience with industry regulations, standards, and guidelines, eg, ICH, GCP, validation, 21 CFR Part 11, etc.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Excellent interpersonal, communication, organizational, and project management skills
- Excellent presentation and writing skills
- Knowledge of ARISg 5.1 Application Series
- Experience with multiple platforms, eg, UNIX, Windows 2003
- Understanding of Pharmacovigilance Systems, Terminologies and Process
- Previous Experience supporting Validation project with cGxP Systems
- Experience in Developing Validation Plan and Summary Reports, Functional and Design Documents, and other project documents used to Computer Systems Validation Processes
- Experience developing test plans and designs based on Business and System requirements

WHAT'S IN IT FOR YOU?

- This is a great opportunity to get your foot into the door with a major company!

APPLY NOW!

RECRUITER: Ryan Kronberger

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK.

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Enterprise: IT & Telecom