CSV Validation Specialist

1 week ago


Santa Monica, California, United States USDM Life Sciences Full time
Job Title: CSV Validation Engineer

USDM Life Sciences is seeking an experienced CSV Validation Engineer to support computer system validation initiatives for our clients.

Job Function:

Validation Analyst

Location:

Santa Monica, CA

About USDM Life Sciences

We are a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth.

Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

About the Role

The Validation Engineer will work with facility Subject Matter Experts to document user requirements, update application system User Requirements, Functional, and Design Specifications, and develop Installation Qualifications based on Design.

The ideal candidate will have a thorough understanding of the principles of computer systems validation, SDLC methodologies, and testing best practices.

Responsibilities:
  1. Work with facility Subject Matter Experts to document user requirements.
  2. Update application system User Requirements, Functional, and Design Specifications.
  3. Develop Installation Qualifications based on Design.
  4. Develop Operation Qualifications based on functional requirements.
  5. Develop Performance Qualification scripts based on configuration.
  6. Perform test execution or lead execution activity.
  7. Route validation documentation.
Requirements:
  • Validation experience with enterprise computer systems (ERP, LIMS, QMS, ECM, LMS, etc.) within the pharmaceutical industry.
  • Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation.
  • Thorough understanding of the principles of computer systems validation, SDLC methodologies, and testing best practices.
  • Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
  • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
  • Strong technical background.
  • Strong communication and interpersonal skills ensuring the ability to interact with the business, peers, and vendors in a professional manner.
  • Ability to work independently with minimal supervision and adhere to timelines.
  • Quick learner.
  • Expert in MS Word.
Benefits

USDM Life Sciences offers a competitive salary/hourly rate range of USD 55.00 - 75.00, health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Full-time employees are eligible for paid time off, and all employees are eligible for USDM's rewards and recognition program.



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