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Validation Engineer
Cellares
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See open jobs at Cellares.See open jobs similar to "Validation Engineer" 8VC.South San Francisco, CA, USA
Posted on Thursday, January 11, 2024
Position Summary
We are seeking a Validation Engineer who will play a key role in establishing and managing the validation programs ensuring alignment with regulatory expectations.
The primary focus of this position will be responsible for driving and managing the commissioning, qualification and validation life cycle and programs for the Cellares cGMP cell & gene therapy facility. This position will oversee the qualification and validation lifecycle activities of the facilities/clean rooms, utility systems/equipment /cleaning and computerized systems, develop and execute validation/ qualification protocols (IQ/OQ/PQ), risk assessments, system impact assessments, summary reports, SOPs and other technical documents. The ideal candidate is an experienced validation engineer with solid experience working in 21 CFR parts 210, 211, 820 and 21 CFR part 11 regulated environments with a deep understanding of ISO 14644-1 and sterile drug manufacturing requirements.
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.
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, FS, project plans, Validation Master Lists
- Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility
- Review validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systems
- Support in building quality management systems necessary for compliant software & systems development, validation, and verification as described in current GMP and GAMP guidance
- Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems
- Lead Quality initiatives for new GMP Aseptic product facility construction and clean rooms qualification in accordance with ISO 14644 and EU Annex 1 requirements
- Support vendor qualification activities including risk assessments and audits
- Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports and drive root cause analysis investigations and CAPAs
- Support the change control program with respect to facility, equipment, utility and computer validation changes. Support the Information Technology change control program for computerized systems. Evaluate validation impact of equipment upgrades, deviations and product non conformance events
- Develop and follow written SOPs, as required, for current Good Manufacturing Practices (cGMP)
- Oversee employees and contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, Equipment and Computerized systems
- Provide training and guidance on Quality Assurance topics to foster a quality culture and quality mindset
- Actively participate in continuous improvement activities with cross-functional teams
- Identify gaps and strategize on solutions, develop a team to drive the solutions
- Analyze process data and perform trend analyses on critical processes to facilitate continuous improvement initiatives
- Develop and implement quality plans and provide guidance to the teams
- Mentoring and training junior level engineers
- Participating in regulatory inspections
Requirements
- Minimum of a Bachelor's degree (or equivalent) in 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
- Must have strong leadership and management skills with experience forming and leading high performance teams
- Detailed knowledge of 21 CFR Part 210,211, Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) and ISO 14644-1 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 and passionate about advancing the field of cell therapies
- Self-awareness, integrity, authenticity, and a growth mindset
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.
This job is no longer accepting applications
See open jobs at Cellares.See open jobs similar to "Validation Engineer" 8VC.