Demo

Validation Specialist

United Pharma Technologies Inc
Thousand Oaks, CA Full Time
POSTED ON 3/10/2025
AVAILABLE BEFORE 6/9/2025

Job Title : Validation Specialist (PAS-X)

Location : Thousand Oaks, California (Onsite)

Overview :

We are seeking Validation Specialists with hands-on experience in PAS-X to support a long-term project in the Thousand Oaks, CA region. This project is expected to continue through 2025 with a high likelihood of extension into 2026 .

Key Responsibilities :

  • Develop, execute, and review validation documentation related to PAS-X , including validation protocols (IQ, OQ, PQ), test scripts, and reports.
  • Ensure compliance with GMP regulations , FDA guidelines , and internal quality standards.
  • Collaborate with cross-functional teams including Quality, IT, Manufacturing, and Engineering to ensure successful implementation and validation of PAS-X systems.
  • Support system configuration, user acceptance testing (UAT), and change control processes.
  • Troubleshoot validation issues and deviations, ensuring timely resolution.
  • Maintain accurate and organized validation documentation and records in alignment with project timelines.

Required Qualifications :

  • Minimum 5 years of experience as a Validation Specialist in the pharmaceutical / biotech industry.
  • Demonstrated experience with PAS-X validation is required.
  • Strong understanding of GMP, 21 CFR Part 11, and validation lifecycle processes (VMP, IQ, OQ, PQ) .
  • Ability to work independently as well as within a team environment.
  • Excellent documentation and communication skills.
  • Preferred Qualifications :

  • Experience working on large-scale system implementations or upgrades.
  • Familiarity with process automation systems and their integration with PAS-X.
  • Knowledge of CSV (Computer System Validation) and data integrity principles.
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