Job Description

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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