Senior Quality Assurance Engineer

Senior Quality 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. 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 Senior Quality Engineer is responsible for managing and performing a wide variety of Quality Engineering activities in support of activities needed to meet company objectives. The role is expected to provide Quality Engineering support and expertise for the maintaining and enhancing, in a phase-appropriate manner, the quality and compliance aspects of our validation, calibration, risk management and facility maintenance programs.

Essential Functions

• Independently review and approve equipment, facility, and instrument IQ/OQ/PQ and process validation protocols and reports.
• Independently review and approve Computer System Validation protocols and reports.
• Assess validation, qualification and/or requalification, calibration, and maintenance requirements of all GMP equipment, instruments, and facilities in collaboration with equipment owners.
• Review, revise, and approve Standard Operating Procedures, study protocols, and reports.
• Perform risk analyses using tools such as, but not limited to, Hazard Analysis, FMEA, FTA, HACCP, etc.
• Perform statistical analysis, where appropriate and based on risk, to support various studies.
• Provides training on risk assessments and statistical process control.
• Perform or support CAPAs arising from engineering and validation issues.
• Perform root cause analysis with tools such as, but not limited to, Ishikawa, A3, 5 Whys, Is – Is not, using six sigma DMAIC methodology, etc.
• Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability, and efficiency improvement objectives.
• Conducts internal auditing activities to ensure that systems are operated per established SOPs and GMPs.
• Supports preparation for regulatory agency inspections and participates as a Subject Matter Expert during regulatory GMP inspections if required.
• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters that arise are addressed in an open and timely manner.
• Supports and actively engages to achieve department and site goals and objectives.
• Organize and manage data relating to Quality Engineering activities.
• Provide status reports, including relevant quality metrics.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor's degree in engineering, Biomedical Engineering, Chemical Engineering, Biotechnology or other relevant science degrees is required.
• 5+ years of experience in the pharmaceutical/biopharmaceutical industry is required.
• 2+ years of experience in related Quality Engineering is required.
• Experience in aseptic processing is preferred.
• Experience supporting internal/external compliance and regulatory audits is preferred.
• Prior statistical software experience is preferred.
• Experience with GAMP 5 preferred.

Knowledge, Skills, & Abilities

• Strong knowledge of biologics cGMP manufacturing.
• Strong knowledge of cGMP facility design, control, and automation
• Proven ability to work independently, analyze, and resolve issues.
• Attention to detail with strong analytical and problem-solving skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple…