Validation Engineer

Validation Engineer
Category: EngineeringTech
Location: Camarillo, CA
Hours: 40 Monday to Friday 8am to 5pm

Career Opportunity Available in Camarillo

Job Description

• The Validation Engineer will collaborate with stakeholders at all locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various testprocess validation requirements.
• Individual will lead cross functional teams to ensure product or process verification supports all internal and product compliance requirements.
• Consult with management, evaluate customer requirements, and studies product characteristics to select validation objectives and standards. Prepare protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
• Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications. Maintain technical records within design history files associated with assigned products.
• Collaborate and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing. Identify root causes of production problems.
• Identify nonconformities of product or process standard and offers recommendations for resolving deviations. Develop and maintain databases for tracking test results, validation activities, or validated systems. Develop, maintain, or review validation and compliance documentation including schematics, protocols, and engineering change notices.
• Modify testing methods, revisit test objectives and standards to resolve testing problems.
• Calibrate equipment to ensure accurate measurements. Develop test methods, generate, and maintain design specifications, protocol report writing, prototyping, DOESPC product optimization, design verification validation, FMEA, etc.
• Participate in system-level and subsystem-level root cause investigation from firmware and electrical perspective, coordinate design improvements with development partners, tactical planning, and execution of design changes and improvements.
• Support Product Delivery Teams PDT, including creating and or reviewi

Skills Required

• BA Degree in Biology, Business, Eng or similar.
• 8+ yrs exp in quality operations within a biotech or pharmaceutical manufacturing facility.
• 3+ yrs validation eng exp.
• Proficient in MS Office.

Skills Preferred

• Masters Degree in Science or Engineering can substitute some exp.