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Validation Engineer II


South San Francisco, CA 94080
  • Facilities
  • Engineering
  • Manufacturing / Production
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Job Details

The Validation Engineer II will be responsible for a variety of validation engineering related activities and for resolving challenging issues following cGMP regulations and Roche standards. This position requires a problem solving mindset with strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation and other groups.

General Job Responsibilities

  • Apply risk based principles and strategies in the qualification of manufacturing systems and utilities used in the production of clinical and commercial manufacturing, packaging, and warehousing of drug substances and drug products.
  • Maintain the qualified state of manufacturing systems throughout the system lifecycle in compliance with current Good Manufacturing Practices (cGMP), general regulatory agency expectations, and Genentech/Roche Quality policies/procedures including support of periodic review, event/time based requalification, and decommissioning.
  • Serve as the Validation technical subject matter expert (SME) in support of department, cross-functional, and network initiatives.

  • Maintain a state of inspection readiness and act as SME in Health Authority inspections.
  • Provide input to the development of personal performance goals and departmental objectives.
  • Collaborate with Management to establish and meet targets and timelines.
  • Manage competing priorities.
  • Identify, design, and implement process and system improvements.
  • Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
  • Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships.
  • Train personnel and internal customers on relevant business processes.
  • Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
  • Be accountable for behaviors as described in Genentechs Core, Common, and Critical Competencies.
  • Carry out responsibilities in accordance with the company policies and procedures.

Specific Job Responsibilities

  • Responsible for developing validation strategy and coordinating validation activities required to complete large scale validation projects (equipment including SUTs, utilities, and facility etc.) in support of the SSFP operations according to the Genentech quality and safety policies, SOPs, and cGMP regulations.
  • Manage the validation deliverables of these projects (equipment including SUTs, utility, and facility etc.) ensuring new equipment and systems are implemented within predetermined timelines and financial forecasts, escalating any potential misses and develop remediation plans when possible.
  • Lead cross functional teams/initiatives and act as individual contributor to drive validation activities, change control and improvement projects, including projects aimed at improving Right-First-Time performance, and value capture projects to improve yield, reduce cost, or lower our processing cycle times.
  • Review/approve validation deliverable documents like protocols, plans, etc., execute studies and report results/conclusions utilizing sound science-based rationales and engineering principles to support SSFP qualification projects as required per current Good Manufacturing Practices (cGMPs).
  • Author, review and approve Change Control documentations for complex validation, equipment, facility/utility and/or automation changes. Manage on-time implementation and close-out to meet project, production and supply timelines.
  • Prepare source documentation for regulatory filings as assigned, may support and serve as a lead SME during regulatory inspections related to investigations, projects and validation.
  • Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
  • Procure and manage contractor support for outsourced validation assignments.
  • Provide input into the design and presentation of department performance metrics.


  • Bachelor's degree in Engineering, Life Sciences, or related discipline with 5+ years of relevant experience, or combination of experience and relevant advanced degree, focused on validation preferably in biopharma manufacturing role.
  • Technical expertise to define validation approaches and execute validation activities in accordance with cGMP and applicable regulations, procedures and industry guidance.

  • A desire to learn and a passion to contribute

  • A collaborative spirit and strong project management capabilities.

  • Knowledge and experience with ASTM E2500 validation approach is preferred.

  • Ability to independently evaluate technical challenges and propose potential solutions.
  • Ability to communicate clearly and professionally in writing and verbally.

  • Basic understanding of data and statistical analysis

  • Flexibility with work hours to meet business needs.

  • Must embrace and encourage diversity and inclusion, and possess the willingness to challenge the status quo.




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