AVANTOR: Senior Validation Engineer

Primary Responsibilities

• Oversee and review validation area processes and procedures

• Responsible for the theory and content of validation documents for equipment, processes, systems, software, changes and ongoing review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies

• Provide facility, equipment, and process qualification technical expertise

• Author and approve validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes

• Coordinate and lead validations to assure compliance with customers requirements, ISO 9001 & 13485, 21 CFR 210 & 211, ICH Q7, 21CFR 820, as needed

• Interface effectively with management personnel in IT, Engineering, Quality, R&D, Sales, and other technical disciplines

• Provide technical decision-making regarding validation strategies and requirements for large scale and complex projects

• Perform, coordinate, and manage qualification testing

• Coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 / ISO 13485, 21 CFR 210 & 211, ICH Q7 and 21CFR 820

• Prepare, write, and review validation protocols, and documentation to ensure compliance and adherence to AMRESCOs SOPs, Customer specifications, ISO9001, ISO 13485, Ich Q7, 21CFR820 and other applicable regulations this includes regulatory bodies in the U.S. and International

• Review the need for validation with design group, all processes, equipment, methods etc.

• Perform validation and manage large-size validation projects and supervise technicians/engineers, providing necessary leadership and guidance

• Responsible for the generation of protocols using a risk-based approach that meets current regulatory requirements and industry practices, as well as performing design qualification