Validation Engineer

No C2C, C2H, or suppliers for this position!

Currently I have an opening for a Validation Engineer located in Oceanside, CA. Details for the position are as follows:

Job Description:

• A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.
• Lead or support cleaning, equipment, utilities, sterilization, and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR) or routine re-qualification activities
• Ensure the timely completion of Cleaning Monitoring as well as validation team assignments.
• Any deviations, anomalies or schedule impacting items are to be reported to site management.
• This position provides trained technical resources for the development and execution of validation protocols in accordance with OCN and global procedures. The person will maintain up-to-date training status in the Cornerstone (or equivalent) system.
• Author and review qualification protocols, engineering change orders, SOP changes, Engineering commissioning and turnover packages. Approval support of any qualification protocols will require approval of the site Validation as well as Quality
• Review Planned/Unplanned events and provide initial assessment for validation lead.
• Review of lifecycle documents for migration into new electronic system as well as for additional changes for MAR, Tech transfer.
• Responsible for on-time completion of validation activities according to overall current manufacturing schedule.
• Ensure coordination of Validation requirements with Quality, Manufacturing & Engineering.
• Bachelors or masters graduate required with professional experience in biotech/pharma/medical device performing facility, equipment, computer validation, cleaning validation (preferred!), utilities, sterilization and/or autoclave qualification.

Technical Information:

• Pay: $75-99 hourly (W2 Only!), depending on experience level
• Onsite position, M-F, 8am-430pm
• 9-month contract, potential for extension/conversion