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Computer System Validation (CSV) Manager

Cellares

Cellares

South San Francisco, CA, USA
Posted on Tuesday, March 7, 2023
Position Summary
Cellares is seeking an innovative and highly motivated Computer System Validation (CSV) manager who will be part of Cellares’ Quality group. This person will actively lead all aspects of Computer System Validation in a GMP-regulated environment and ensure compliance with cGMP, 21 CFR Part 11, EU Annex 11 and GAMP 5 regulations.
This individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop and validate the best compliant solutions possible. The successful candidate should have direct experience in all activities throughout the Validation lifecycle in the Pharmaceutical, Biotech, Medical Device industries for custom applications and components (category 5), infrastructure software, tools and IT services (category 1) and standard/configured systems (categories 3 and 4).
The candidate should be proficient with various types of testing during design and development to commissioning, FAT, and SAT to formal validation (IQ, OQ, PQ, UAT) in various testing environments (Development/Sandbox, Test/Validation, Production). The candidate should understand the system lifecycle from supplier evaluation, purchase, development, installation, testing, operation, maintenance, and system retirement. The candidate should be detail-oriented and possess strong analytical and problem-solving skills.

Responsibilities

  • Generate and develop qualification and validation lifecycle documents, templates, protocols, reports; including but not limited to the following, SOPs related to the CSV programs, Risk Assessments, System Impact Assessments, Validation Master Plans, URS, FS, project plans, Validation Master Lists
  • Support, review, and approve documentation associated with validation planning, intended use, user requirements, hazard analysis, risk assessments, functional/design specifications, design reviews, design V&V packages, test protocols, 21 CFR Part 11 compliance assessments, requirements trace matrix, Master Validation Plan and validation report
  • Develop, review, and approve CSV protocols (IQ, OQ, PQ), coordinate execution of testing, and generation, review, and approval of validation reports
  • Ensure that cGMP and Change Control related CSV, and IT systems are established, implemented, and maintained to ensure regulatory compliance, data integrity, and to optimize efficient and effective business processes
  • Act as an effective leader in supporting Software Quality Assurance (CSA) and IT disciplines, decisions, and practices
  • Coach/Mentor Quality, Engineering, and other technical team personnel
  • Provide direction to project teams on CSV and quality implementation processes and interpretation of procedural compliance requirements
  • Review and approve changes to existing systems, ensuring changes are implemented in compliance with internal procedures and external standards
  • Oversee contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, Equipment and Computerized systems
  • Review test results for Good Documentation Practices (GDP) compliance and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed
  • Ensure the best quality practices are employed by all departments so that software/firmware based systems are developed, qualified, and maintained in a manner which provides assurance that the system conforms to both internal and external requirements
  • Author Standard Operating Procedures (SOPs) as required
  • Lead CSV related investigations and deviations generated during and post validation activities
  • As required, support audits, non-conforming events and CAPAs
  • Establish and promote an environment that supports the Quality Policy, cGMP, Data Integrity, and Quality Systems

Requirements

  • Bachelor's level degree or higher in Science, Engineering, or Software discipline
  • 5+ years of related work experience in Validation for CSV and Automation.
  • Must have strong management and organization skills with experience leading high performance teams or contractors
  • Experience working in an FDA-regulated industry
  • Knowledge of System Development Life Cycles (SDLC) preferably with automated manufacturing and computerized lab systems
  • Knowledge of Validation Life Cycles (VLC) and applied experience in FUE, CSV, Automation, QC systems
  • Understanding of risk-based validation and data integrity requirements to perform assessments or apply applicable testing strategies
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.