Principal Validation Engineer

Principal Validation Engineer

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. 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 Principal Validation Engineer 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 an FDA regulated biopharmaceutical environment. This includes management of contractors as they supplement validation staff during expansion activities.

Essential Functions

• Provide validation focused design and development by engaging with cross-functional teams to define requirements, design, verification and validation plan and strategies.
• Generate and execute validation protocols (IQ/OQ/PQ) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment.
• Provide technical project management for certain phases of a project such as scheduling, design, engineering specifications, drawings, and materials procurement.
• Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
• Perform risk assessments for GMP systems as required and plan validation efforts according to risk.
• Evaluate systems for potential process improvements utilizing Lean Six Sigma or Quality by Design approaches as applicable.
• Supports managers hold delivery teams accountable for their assignments.
• Manage contractors, projects and timelines. Coordinate multiple projects and shifting priorities.
• Mentors and guides a team of junior Validation Engineers in the validation work performed across multiple teams and projects.
• Train end users on validation policies and requirements to support GMP operations.
• Collaborate with clients, CMO's, and vendors to meet project and company objectives.
• Participate in audits and regulatory agency inspections for Validation.
• Serve as subject matter expert in qualification and validation.
• Troubleshoot and coordinate failure investigations for manufacturing and laboratory equipment.
• Assist with vendor communications and maintenance/repair scheduling.
• Resolve deviations and non-conformances reported during validation/qualification.
• Assist with engineering studies and investigations in other departments and perform any additional responsibilities as requested or assigned.
• Generate and keep current inventory of GMP systems and requalification/revalidation schedules.
• Create, edit and adhere to Standard Operating Procedures (SOPs) and process improvements as needed.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education and Experience

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

Knowledge, skills and Abilities

• Excellent technical document writing and reviewing with teams.
• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities.
• Experience with and knowledge of related quality systems such as change control; CAPA (including deviations/OOSs);
  Risk Assessment (FMEA): training and document control are required.
• Experience with ELLAB data loggers and systems (preferred)
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and clean rooms, automated biopharmaceutical processing and plant equipment
• Working…