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Lead Validation Engineer

Company: Biotech
Location: thousand oaks
Posted on: May 3, 2021

Job Description:

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.We focus on providing quality consulting services to ensure our client u2019s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer u2019s expectations.We are looking for a Lead Validation Engineer. This position can be done mostly remotely. Responsibilities Responsible for delivering and managing the entire commission effort. Interface with project commission & qualification lead to complete upfront planning and ensure that the program requirements are met. Develop, drive, and track progress against the execution schedule. Facilitate meetings to coordinate activities, produce meeting notes and track and drive closure of open items Interface and manage participation of other participants in the commission effort Ensure staffing levels are appropriate to support the schedule and manage the execution level personnel. Periodic review of equipment. Periodic review of controlled temperature chambers. Periodic review of computerized system u2013 Includes assessing systems to be enrolled in computerized system periodic review. Annual Product Review (systems list) reporting for commercial equipment. Validation Master Plan ownership. Deviation and CAPA Ownership and Support related to Validation Maintenance issues. Validation Change Control assessments. Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems (QRAES). Performance tracking and metric reporting. Execute qualification/validation for new/modified equipment. Requirements Team members should have experience with working in operational facilities and understand how to interface with production personnel. Experience with single use, skidded/portable manufacturing systems for biologic processes. Training or experience with commissioning & qualification of automation systems (Direct experience commissioning Delta V systems) Facilitate meetings with several parties (external and internal)

Keywords: Biotech, Thousand Oaks , Lead Validation Engineer, Other , thousand oaks, California

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