Validation Engineer in Santa Monica, CA

Summary:

• Responsible for performing the validation of computerized systems, and automation systems for projects.
• This includes developing validation master plans with minimum supervision, pre and post-review of protocols independently, and preparing technical reports.
• Contributes directly to the completion of validation projects through the development of validation schedules, and master plans, which may be complex in nature, to support clinical and commercial manufacturing.

Job Responsibilities:

• Participate in meetings (status updates, aligning with stakeholders, resolving questions from cross-functional teams)
• Client change control records (pre-approval and action items, completed action items, CC closure)
• Draft plans (Validation Plan) and draft VSR
• Reviews (SDLC documents, post-executions, EC’s)
• Hotfixes/emergency fixes (review TIA, review evidence)

Qualifications:

• Have at least 10+ years of experience leading CSV projects from beginning to end in a GMP-regulated biotech/pharmaceutical company, creating all SDLC documents, data migrations, system decommissioning
• Familiar with regulations 21 CFR Part 11, EU Annex 11, data integrity principles, GDP
• Quick learner and extremely efficient
• Experience in a startup or fast-paced company, nice to have experience in a cell therapy company
• Extremely detail-oriented
• Good in taking direction
• Effective communicator
• Engineering background preferred

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