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Avantor Manager - Validation Engineering in Devens, Massachusetts

Job Summary Establish and maintain procedures and techniques for Quality Assurance Activities. Assist in the coordination of manufacturing and engineering and confers with customers to define and resolve product quality issues. Interact with Leadership to advise necessary continuous improvement efforts so that systems and processes are in line with overall company strategy and quality policy. Provide technical input and implement process and documentation changes. Manages a large team of experienced professionals with a focus on policy and strategy implementation, as well as implementing short-term operational plans. The Manager - Validation Engineering will provide specialized knowledge in developing the strategy for equipment for processes and works with the validation team to ensure proper installation, operational and performance qualification of each piece of equipment up to and including all associated documentation. This includes products for medical device, excipient and bio-pharma manufacturing. Prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. The role is responsible for the theory and content of validation documents for equipment, processes, systems, software, changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation documents and execute validations of equipment, control systems and production processes. Directs the life cycle of launched products to support development of manufacturing processes, drive right-first time metrics, and reduce product rejects. Has responsibility for self-identification of process optimization opportunities, and detailed assessment of opportunities (process risk, financial cost/benefits, etc.). Participates in cross-functional assessments, as required to evaluate optimization opportunities/issues. Coordinate and lead validations to assure compliance with customer?s requirements, ISO 9001 & 13485, 21 CFR 210 & 211 and 21CFR 820 MAJOR JOB DUTIES AND RESPONSIBILITIES Interface effectively with management personnel in IT, Engineering, Operations, R&D, Sales and other technical disciplines. Provide technical decision making regarding validation strategies and requirements for large scale and complex projects. Create Standard Operating Procedures and training materials. 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. Perform, coordinate and manage qualification testing. Represent Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDA management personnel in regards to validation activities. 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 and 21CFR 820. Identify any areas for improvement and propose / implement approved necessary changes. Prepares, writes and reviews validation protocols, Master Validation Plan (MVP), and documentation to ensure compliance and adherence to Customer specifications, ISO9001, ISO 13485, 21CFR820 and other applicable regulations. This includes regulatory bodies in the US and International. Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected. Review need for validation with design group all processes, equipment, methods etc. Responsible for performing validation and managing large size validation projects and supe

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