Senior Quality Validation Specialist

We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the Cellares team. The Quality Validation team at our IDMO Bridgewater facility will be responsible for providing Quality Assurance oversight of environmental, equipment (analytical and production), facility & utility, site automation, process validation & engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. This individual will work closely with cross-functional teams to maintain high standards of quality in a regulated environment. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows. This is Cellares Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing. Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process. Responsibilities Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc. Author and maintain the IDMO Site Validation Plan Provide Quality oversight of process validation studies and process performance qualifications Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification & recertification, cleaning & sanitization, and facility controls Proactively identify & resolve technical and compliance issues/gaps Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.) Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports Act as Quality Engineering Subject Matter Expert for responsible areas/projects during client or regulatory inspections Drive continuous improvement and increase efficiency and productivity Requirements Bachelor’s degree in a scientific or engineering discipline 5 to 8 years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC 2+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations Excellent knowledge of the regulations for biologics, cell and gene therapy products Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is desirable Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches Excellent understanding of risk management and CAPA processes Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy Experience with computerized systems validation (CSV) is a plus.

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      "text": "Responsibilities",
      "content": "\n<li>Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.</li>\n<li>Author and maintain the IDMO Site Validation Plan</li>\n<li>Provide Quality oversight of process validation studies and process performance qualifications</li>\n<li>Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification &amp; recertification, cleaning &amp; sanitization, and facility controls</li>\n<li>Proactively identify &amp; resolve technical and compliance issues/gaps</li>\n<li>Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge</li>\n<li>Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)</li>\n<li>Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports</li>\n<li>Act as Quality Engineering Subject Matter Expert for responsible areas/projects during client or regulatory inspections</li>\n<li>Drive continuous improvement and increase efficiency and productivity</li>\n"
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