Senior Validation Engineer at The Fountain Group

The Senior Validation Engineer plans, implements and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. This position is onsite in Oceanside, CA.
 
Duties:

• 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.
• Ensure the integration of environmental health, safety, and security into the business processes, systems and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Foster a positive safety culture in which no one gets hurt.

• BA/BS in Engineering or Life Sciences
• 5+ years of relevant validation engineer experience
• Expert in current validation requirements and FDA expectation of facility, equipment, and computer validation
• Ability to establish and maintain good relationships with various site functional groups as well as external validation contractors and consultants
• Ability to manage and track validation progress in required detail with data basis and schedules

• Excellent teamwork, communication and problem solving skills