Senior Validation EngineerWe are seeking a Senior Validation Engineer with solid hands-on validation experience and a collaborative mindset to help drive validation harmonization across the Cellares global landscape. The primary focus of this position will be responsible for execution activities for QC and Manufacturing equipment. In addition to many of the equipment seen at traditional cell & gene therapy facilities, this position will focus on the qualification and validation of several Cellares proprietary equipment. The ideal candidate for this position will have not only a deep understanding of qualification and validation lifecycle activities across all manufacturing process streams, but also have the ability to apply that knowledge base to the Cellares Cell Shuttle and Cell Q.
In addition to equipment qualification and validation, the person in this position will also execute facilities and utility systems. The desired candidate will be very hands-on with execution, but also develop documentation; validation/qualification protocols (IQ/OQ/PQ), risk assessments, system impact assessments, summary reports, SOPs and other technical documents. This position, at times, will require the oversight of contract workers, junior level engineers and equipment vendors.Candidates should enjoy working in a fast-paced, mission-driven environment, be comfortable with using justified risk based approaches, and be prepared to tackle a broad selection of challenges as the company grows.ResponsibilitiesGenerate and develop qualification and validation lifecycle documents, templates, protocols, reports including but not limited to the following: SOPs related to the commissioning, qualification and validation programs, Risk Assessments, System Impact Assessments, Validation Master Plans, URS, project plans, Validation Master ListsReview validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systemsEnsure maintenance of validated status via Periodic Review (PR) and requalification activitiesKnowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systemsKnowledge of Data Integrity and ALCOA+ principles and the applicability to process and analytical systemsKnowledge of QC equipment validation as it relates to the interface of IOQ and method validationSupport vendor qualification activities including risk assessments and participate in selection of vendors that support validation effortSupport the change control program with respect to facility, equipment, and utility validation changesEvaluate validation impact of equipment introduction/upgrades and software/hardware changesFollow written SOPs, and ensure SOP training remains currentOversee contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, and EquipmentProvide guidance on topics to foster a quality culture and quality mindsetActively participate in continuous improvement activities with cross-functional teamsProvide status updates to stakeholders and internal customers of validation activities in their respective areasIdentify qualification/validation gaps, strategize on solutions, drive gap mitigationMentoring and training junior level engineersFoster collaborative approach to ensure harmonization of qualification/validation approach across all Cellares sitesParticipate in regulatory inspectionsRequirementsMinimum of a Bachelor's degree in Engineering or a scientific related field and 8 years of experience working in a GMP regulated environmentMinimum of 5 years qualification and validation hands on experienceDetailed knowledge of 21 CFR Part 210,211, Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) requirementsKnowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11)Excellent technical writing skills with an understanding of good documentation practiceSelf-motivated, detail-oriented and passionate about advancing the field of cell therapiesCollaborative, solution oriented, comfortable in an agile environment$90,000 - $210,000 a year Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.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.