Validation Engineer II

Validation Engineer IIHybrid/Onsite in Emeryville, CADirect Hire The Validation Engineer II is responsible for the application of the Agenus risk-based approach to qualification and validation of manufacturing and laboratory equipment and computerized systems used to ensure cGMP/Part 11 compliance. Roles and Responsibilities: Generate, support, and/or execute commissioning and qualification/validation deliverables as per Agenus procedures, such as, but not limited to: validation plans, users requirements, functional specifications, requirements traceability matrices, protocols (FAT, SAT, IQ/OQ, PQ) and final reports summarizing testing activities and deviations across a wide variety of equipment, utilities and lab instrumentation systems used in the biopharmaceutical industry. Develop qualification/validation schedules for startup of new, modified, and existing facilities, equipment, and systems. Maintain inspection readiness of equipment and computerized system validation documents, including tracking and archiving of validation documents. Contribute to and review change controls, deviations, investigations, CAPAs, and risk assessments. Contribute to the generation, review, and approval of system design documentation, including Design Specifications, System P&IDs, System Impact Assessments, Functionality Assessments, and Component Criticality Assessments. Support the implementation of the Validation Periodic Review Program. Provide facilities, utilities, and equipment validation data for quarterly management reviews and for batch summaries. Qualifications: Experience with current US and international regulations, guidance, and industry best practices in the following areas of validation: startup, commissioning and qualification, equipment, and computerized systems validation. Experience with process validation is a plus. 8+ years in related work experience in a biotechnology and/or pharmaceutical GMP manufacturing environment. Education Requirements: Requires a minimum B.S. degree in Engineering (e.g., Mechanical, Electrical, Computer, Chemical or Biomedical) or related discipline. Any additional certifications are a plus (e.g., ASQ-CQA, CQE, CSQE, among others). Preferred Skills: Must possess good interpersonal, communication, and team skills. Strong focus on quality. Basic understanding and working experience in the development of GMP documentation to support the qualification and validation of GMP equipment and systems. Familiarity with the basics of metrology. Experience in technical writing: (e.g. protocol generation and report authoring). Provide facilities, utilities, and equipment validation data for quarterly management reviews and for batch summaries. Competencies Needed: Experience with current US and international regulations, guidance, and industry best practices in the following areas of validation: startup, commissioning and qualification, equipment, and computerized systems High execution: Demonstrates and fosters a winning mind set, a sense of urgency, optimism, and ownership, and a strong drive to achieve goals and organizational success. Collaboration: Demonstrated ability to work cross-functionally, manage crises and align interests of multiple parties. Detail Orientation: Ability to bring laser focus and attention to detail to critical projects, comfort operating in the weeds without losing sight of the big picture, aptitude for mastering operational specifics of each project to facilitate its efficient advancement.

Created: 2021-11-29