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Aerotek Validation Engineer in San Diego, California

Description:

The Senior Validation Engineer will oversee development and execution of validation master plans and identify approaches based on risk. The Validation Engineer will also oversee other Validation Engineers and consultants as well as develop, scale up, optimize, evaluate, and calibrate equipment, systems, and write procedures and protocols. The Validation Engineer will also manage timelines, metrics, scope, and site reporting requirements.

Skills:

Validation, Gmp, Validation protocols, iq oq, pq

Top Skills Details:

Validation

Medical Device

Pharma

Additional Skills & Qualifications:

• Independently manages other validation engineers and/or consultants, tracks overall validation master plan progress and provides dashboard updates to senior management

• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards

• Develops validation strategies and approaches consistent with all applicable site guidance documents and writes protocols for validation or performance testing of manufacturing equipment, processes, or systems

• Applies current validation best practices and knowledge of risk-based validation approaches across a wide range of manufacturing sub-assembly and assembly processes.

• Executes qualifications and validations as needed

• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications

• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing

• Identifies root causes of production problems

• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations

• Develops and maintains databases for tracking test results, validation activities, or validated systems

Experience Level:

Expert Level

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About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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