Job Description

As a Validation Project Manager, you will be responsible for one or more projects within the Validation Group. You will coordinate the validation project team and ensure that we plan, prepare, execute, and evaluate all required tests during cell development.

A Validation Manager oversees and validates manufacturing plants' daily operations, ensuring compliance with standards and regulations. They often inspect information technology systems and machinery, review specifications and documentation, gather and analyse feedback, and observe various areas' maintenance procedures. It is also their responsibility to manage validation teams, supervising them while implementing policies and regulations. Moreover, a Validation Manager develops validation plans for various facilities and produces detailed reports, along with recommendations and conclusions.

Essential Duties and Responsibilities:

• Act as a single validation contact point to assigned validation project(s)
• Collaborate with stakeholders to define project scope, goals, dependencies, and deliverables.
• Collect and review requirements to ensure product eligibility for system compatibility testing.
• Responsible for cross-functional team communication and weekly status monitoring of project(s)
• Work with related teams to maintain system qualified component list (QCL) during product development stage.
• Collaborate with internal teams for continuous process improvement and software tool enhancements.
• Continual knowledge development of current and new server products and technology

Qualifications:

• B.E. in electrical or computer related engineering field is preferred.
• Minimum 5 years of experience in project management
• Minimum 3 years of experience in servers/computer industry is preferred.
• Knowledge of product development processes including waterfall and agile method is preferred.
• Strong interpersonal skills with ability to collaborate and delegate with cross-functional teams.
• Self-motivated and proactive with problem-solving skills and critical thinking capabilities
• Proficiency in presentation and spreadsheet software

Validation Manager Responsibilities

• Manage the CSV project
• Implement a regression process, and manage the execution of the regression testing.
• Manage an SSD validation team responsible for testing and debugging the next generation PCIe SSD's.
• Manage QA disposition and review of commercial stability material and conduct investigations on out-of-specification/anomalous results.
• Coordinate site training requirements, deliver GMP and technical specific training, create and manage associated metrics.
• Perform computer and control system validation for QC analytical instrumentation and manufacturing process systems.
• Automate projects with PLC, DCS & MMI.
• Revise and approve all commissioning books for GMP and Non-GMP systems.
• Review IQ/OQ/PQ protocols and reports for accuracy, thoroughness and relevancy to the subject matter.
• Serve as validation liaison during FDA and EU regulatory inspections; authorize all validation protocols and process changes.
• Investigate manufacturing and validation deviations, recommend corrective & preventative actions (CAPA), & prepare related technical reports.
• Identify and assign CAPA responsibilities.
• Participate in QA review of RIBC department validation documents
• Participate in FDA regulatory audits and present validation updates.