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CSV Analyst--Periodic Review
Validation Engineer
Hayward, CA

USDM validation analysts will support clients on a variety of compliance initiatives.  We currently have an opportunity for a CSV Analyst who has about 5 yrs. of experience providing Periodic Reviews of Validated Computer systems, experience with validation of IT Application systems such as QMS, LMS, EDMS (Veeva or similar) and lab. Systems such as Empower/Nugenesis, LabX as well as computerized lab instruments such as HPLC/GC, UPLC, UV/VIS, TOC Analyzer, Malvern Rheometer, Beckman particle counter etc. The person should be well versed with respect to Part 11/Annex 11 compliance, data integrity and CSV, with good writing  and speaking skills in professional life science  (pharma/biotech) organizations.
Job Description
•    The validation analyst will provide an advisory role as needed.  This may include:
o    Advising clients on assigning proper risk to computer systems
o    Advising clients on how to meet compliance requirements.
o    Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements.
•    Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements.
•    Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements
•    Develop test / validation scripts based on software / hardware design / configuration
•    Develop Installation tests / qualifications scripts based on Design
•    Develop Operation tests / qualifications scripts based on functional requirements
•    Develop Performance tests / qualification scripts based on configuration
•    Interact in a team environment, managing tasks and escalating issues as needed.

Education & Experience/Technical Competencies:
•    University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
•    Minimum 3 to 5 years in pharmaceutical industry, focusing on Systems Validation.
•    Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
•    Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
•    Expertise in use and validation of GMP systems.

Job Knowledge/Skillsets:
•    Fluent knowledge of rules and regulations: GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
•    Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
•    Ability to work independently.
•    Strong organizational/ facilitation/communication skills.
•    Strong verbal, written and presentation skills.

 

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