Validation Engineer III

Validation Engineer III

Immunity Bio, Inc. is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system.

Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.

The Validation Engineer III is responsible for coordinating all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Prepares all protocols, executing of protocols and reports for validation work in a FDA regulated biopharmaceutical environments. The Validation Engineer III reports to a manager or head of a unit/department. The Validation Engineer III contributes to moderately complex aspects of a project.

Work is generally independent and collaborative in nature. This includes oversight of contractors as we supplement validation staff during expansion activities.

Essential Functions

• Lead interaction and collaboration with cross-functional departments in order to meet company expectations
• Lead and perform validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs, cGMPs, and applicable regulatory requirements
• Generate and execute validation protocols (IQ/OQ/PQ/CV/PV) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment
• Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems
• Generate and keep current inventory of GMP systems and requalification/revalidation schedules
• Perform risk assessments for GMP systems as required
• Plan validation efforts according to risk
• Collaborate with clients, CMO's, and vendors to meet project and company objectives
• Own the communications process with vendors
• Troubleshoot and resolve discrepancies reported during validation/qualification
• Troubleshoot, coordinate, and resolve failure investigations for manufacturing and laboratory equipment
• Provide technical input to assist in development of project planning
• Provide technical project management deliverables for certain phases of a project including but not limited to scheduling, design, estimates, engineering specifications, drawings, materials procurement, construction contracts, cost tracking and project cost projections.
• Partner with engineering studies and investigation studies as applicable
• Lead audits and regulatory agency inspections for Validation
• Serve as subject matter expert in areas of IQ/OQ/PQ at a minimum
• Oversee contractors, projects and timelines
• Coordinate multiple projects and shifting priorities
• Train end users on validation policies and requirements to support GMP operations
• Provide validation assistance to other departments and perform any additional responsibilities as requested or assigned
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Basic Qualifications

• Bachelor's degree in science or related discipline is required.
• 5+ years of relevant validation or GMP-regulated industry experience is required.
• Experience with facility commissioning and validation of equipment and facilities is required.

Preferred Qualifications

• Excellent technical document writing and reviewing with teams
• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities
• Strong knowledge of process validation principles
• Experience with project management concepts
• Experience with and knowledge of related quality systems such…