The Senior Manager, Computer System Validation (CSV) is responsible for leading the GxP system validation activities within the Vacaville Manufacturing Site to ensure that relevant computer systems are in compliance with applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. This role is also responsible for the development of Standard Operating Procedures (SOPs) and templates specifically related to software validation and testing.
The Senior Manager, Computer System Validation also contributes to the development of custom application software as well as Configurable Off-The-Shelf (COTS) systems. Duties include overseeing and executing the validation of new systems; evaluating and performing periodic reviews of existing validated computer systems to ensure / verify continued compliance with appropriate regulations and maintaining required change control procedures.
This position is responsible for the oversight of all CSV initiatives including resource management, spend tracking, and workload forecasting. Other responsibilities of this position include: review and approval of validation deliverables and Software Development Life Cycle (SDLC) documents, contractor management, and other duties as assigned.
The incumbent works cross-functionally with internal departments and external resources on CSV-related issues.
The Senior Manager, Computer System Validation supports adherence to all relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. The Computer System Validation (CSV) Engineer will develop design and test documentation including user requirements, risk assessments (RA), test plans, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification (DQ/IQ/OQ/PQ) tests and validation summary reports.
A thorough knowledge of the Food and Drug (FDA) Code of Federal Regulations (CFRs) and the European Medicines Authority (EMA) including the International Council of Harmonization (ICH) regulations.
Support of internal and HA inspections including defending / presenting Genentech / Roche procedures, methods and validation packages.
Guide and mentor less experiences engineers in the Genentech / Roche Pharmaceutical Quality System (PQS) methodology.
The position requires close teamwork with Process Engineering/Science, Manufacturing, Engineering, Automation, Front Line engineers and related Quality oversight groups to ensure the delivery of appropriate and compliant solutions.
Develop CSV Master Plan for Vacaville Operations including anticipation of new requirements, maintaining validation status of current systems, and developing approaches and plans for new systems
Direct the computer system validation of automation system related projects from internal staff and contractors
Maintains staff by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, work environment; developing personal growth opportunities.
Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
Develop qualification project plans, deployment plans and test plans.
Develop computer system validation test documentation.
Lead risk assessments to determine testing strategies and scope for automation related projects and changes.
Work with internal and external customers to identify and implement improvements within the Technology department related to system development lifecycle (SDLC) and change management business processes.
Develop Good Automated Manufacturing Practice (GAMP) based SDLC related deliverables such as user requirements specifications (URSs) and requirements traceability matrices (RTMs).
Provide site stakeholder feedback to drive improvements to global initiatives, including the Pharmaceutical Quality System, the Engineering Manual and Quality Risk Management program
Represent AESS in audits, investigations and discrepancy resolution.
Provides cross-functional participation to work closely with Manufacturing, Manufacturing Sciences, Engineering, Quality and other interdepartmental staff to meet department and company goals.
Fosters and champions a positive safety culture.
Champions self-initiated or assigned projects within the context of company objectives, and justify goals to management.
Participates on cross-functional teams dedicated to process improvement, efficiency and optimization.
Participates on cross-functional teams aimed at defining best practices and improving process performance.
Presents ideas, project goals and results within AESS and to Technology management.
Foster teamwork and drive project/process improvements.
Communicates proactively with stakeholders and management regarding progress, issues, and plans for resolution.
Expected to participate in cross-functional projects or teams in support of mission
Who You Are
Education and Experience
Bachelor’s degree in engineering, computer science or allied fields
A minimum of 10 years of relevant experience
Demonstrated success in leadership and organizational management in a technical, team orientated environment. With a minimum of 5 years of supervisory experience.
Knowledge, Skills, and Abilities
Five or more years’ experience in requirements analysis, system design, implementation and validation of manufacturing execution and batch control systems in 21 CFR Part 11 compliant GMP manufacturing environments in the pharmaceutical industry.
Thorough understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500.
Practical experience with quality risk management and risk based validation approaches
An established record of successful project completions employing proven engineering and project management skills.
Experience preparing a variety of automation engineering project documentation, including request for proposals, business and functional requirements, design specifications, validation test protocols and technical support documentation.
Ability to organize and solve complex problems through the regular use of ingenuity and innovation.
Strong oral and written communication skills.
Solid understanding of large scale GMP commercial biologic manufacturing.
Strong experience of working in a collaborative team environment with other technical staff.
Highly motivated individual with the ability to work independently as well as with cross-functional teams.
Work Environment/Physical Demands/Safety Considerations
Work in office, utility yard and computer room environment.
May be on feet for 8 to 10 hours a day.
Lift up to 25lbs may be required.
May work in a clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
Work in a “clean” manufacturing environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by steam, water and air.
Access to control panels with low voltage (<600 V) sources present.
Ability to sit, stand and move within work space for extended periods.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.