Job Description

Job Description

A leading pharmaceutical company in Thousand Oaks, CA is seeking a Validation Engineer consultant to join them onsite starting in October 2025. This role is focused on re-qualification and validation maintenance of temperature control units including incubators, off-the-shelf freezers, cold boxes, and ambient warehouse.

Scope of Work:

Objective : To ensure the successful re-qualification of temperature control units through comprehensive qualification activities according to company internal procedures.

Project Description :

• Equipment : CO2 incubators, incubators, and -80 °C Freezers
• Duration : Estimated 4 months within 12 months of calendar year OCT2025, DEC2025, JAN2026, and FEB2026, Full-Time (40hrs/week) for about 700 total hours. The projected schedule is as follows:
• OCT2025 : One (1) CO2 Incubator, and Two (2) -80 °C Freezers
• DEC2025 : Tree (3) CO2 Incubators, and one -80 °C Freezer
• JAN2026 : Four (4) Incubators
• FEB2026: Four (4) CO2 Incubators

Out of Scope

• Validation equipment (Thermocouples, computer, Resistance Temperature Detector (RTD), Data Logger, and Data Acquisition System)

List of Responsibilities:

The responsibilities for the validation resource will be assigned by the Engineering Services Team as needed, and will include but are not limited to the following:

• Calibration: Calibration of Thermocouples per company procedures.
• Installation Qualification (IQ) : Develop documents as coordinator/owner according to company procedures, execute, and complete for closure IQ protocols.
• Operational Qualification (OQ) : Develop documents as coordinator/owner according to company procedures, execute, and complete for closure OQ protocols per validation plans.
• Discrepancies: Initiate and complete protocols discrepancies according to company procedures.
• Traceability Matrix and Summary reports : Function as document coordinator/owner of requirements traceability reports and qualification protocols summary reports.
• Training : Maintain current training on relevant Standard Operating Procedures (SOPs).

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