We 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.
Responsibilities
- Generate 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 Lists
- Review validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systems
- Ensure maintenance of validated status via Periodic Review (PR) and requalification activities
- Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems
- Knowledge of Data Integrity and ALCOA+ principles and the applicability to process and analytical systems
- Knowledge of QC equipment validation as it relates to the interface of IOQ and method validation
- Support vendor qualification activities including risk assessments and participate in selection of vendors that support validation effort
- Support the change control program with respect to facility, equipment, and utility validation changes
- Evaluate validation impact of equipment introduction/upgrades and software/hardware changes
- Follow written SOPs, and ensure SOP training remains current
- Oversee contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, and Equipment
- Provide guidance on topics to foster a quality culture and quality mindset
- Actively participate in continuous improvement activities with cross-functional teams
- Provide status updates to stakeholders and internal customers of validation activities in their respective areas
- Identify qualification/validation gaps, strategize on solutions, drive gap mitigation
- Mentoring and training junior level engineers
- Foster collaborative approach to ensure harmonization of qualification/validation approach across all Cellares sites
- Participate in regulatory inspections
Requirements
- Minimum of a Bachelor's degree in Engineering or a scientific related field and 8 years of experience working in a GMP regulated environment
- Minimum of 5 years qualification and validation hands on experience
- Detailed knowledge of 21 CFR Part 210,211, Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) requirements
- Knowledge 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 practice
- Self-motivated, detail-oriented and passionate about advancing the field of cell therapies
- Collaborative, solution oriented, comfortable in an agile environment
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.
