Position Summary

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 priorities.
• Exceptional organization, flexibility, and time-management skills with ability to deliver under deadlines.
• Familiarity with risk management activities per ISO14971, ISO31000, or ICH Q9.
• Basic lab skill knowledge (cell culture, pipetting, dilutions, titrations, etc.) preferred.
• Statistical Process Control (SPC) or Six Sigma experience preferred.

Working Environment / Physical Environment

• This position works on-site.
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Must be able to lift frequently lift up to 35 pounds and occasionally lift/move 50 pounds

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$108,000 (entry-level qualifications) to $120,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.